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<![CDATA[ The Duke Human Vaccine Institute, a part of Duke University Medical Center, occupies a place of national and international leadership in the fight against major infectious diseases. DHVI currently has an opening for a Research Analyst. The Research Analyst will perform a variety of technical and administrative support duties involved in conducting biomedical research which includes conducting animal experiments, collecting and processing samples from animals to obtain data for research purposes. The Research Analyist will be expected to compile, analyze, document, and draw tentative conclusions from experimental results. Successful candidates will possess a Bachelor's degree in a biological science with a minimum of two years animal handling, injection, anesthetization, and necropsy experience. A Master's degree in microbiology, immunology, cell biology, or a related field is preferred and experience with Immunology assays/methods (in particular, Humoral immune response) and molecular biology techniques is a plus. Only candidates with the required animal experience will be considered. Qualified applicants should submit resume and the name and contact information of the references to: DHVI Human Resources DHVI.Careers@notes.duke.edu Please note "SL -- LRA" in the subject line. Duke University and Health Systems is an Equal Opportunity Employer  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: Commensurate with education and experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Center for Human Genome Variation is seeking an individual to join an interdisciplinary research team investigating, developing, and employing technology platforms to generate high quality genomic data. The successful candidate will manage and facilitate projects and collaborations, establish and provide progress reports, and oversee the management and curation of the Center's repository of samples/cohorts that includes developing databases to house phenotypic and sample data, overseeing the recording for all existing samples, and developing/managing the process and information flow from the project leads. Candidates should possess a bachelor's degree in biology, genetics, or related biological field (Master's degree preferred) with a minimum of two years of molecular biology and project management experience. Previous experience with specimen sample management is preferred. Individual must be highly organized and detail-oriented, show initiative and ability to multi-task, and be willing and able to work independently as well as part of a team. Solid knowledge of computers and databases is required. Qualified applicants should apply to requisition #400579452 and submit resume and cover letter to: Human Resources Center for Human Genome Variation Durham, NC 27708 Email: chgv.careers@notes.duke.edu Please note PP1 in the subject line. Duke University is an Equal Opportunity/Affirmative Action Employer.  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: Relative to experience and education</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Kelly Scientific Resources has recently seen a significant expansion in job opportunities for Quality Control Chemists across the state of North Carolina. We currently have contract-to-hire opportunities available on multiple shifts for Quality Control Chemists in the Eastern North Carolina area. Our client is a leader in the development and manufacturing of specialty injectable pharmaceuticals and they have several opportunities available for Quality Control Chemists seeking immediate employment. Experience Required: - Bachelor's in Chemistry (or related field) with 3 or more years of experience in a pharmaceutical or cGMP environment - Individuals must be able to work independently with little supervision - The ideal candidate will also have experience in analytical instrumentation troubleshooting Primary responsibilities for this position include: - Performing analysis of raw materials, in-process, and finished samples via HPLC, GC, FTIR, KF or wet chemistry techniques - Following SOPS in a GMP environment - Performing stability testing protocols - Investigating analytical problems - Preparing accurate documentation - Troubleshooting equipment - Preparing laboratory media ***Relocation and travel assistance will not be available for these opportunities. For immediate consideration, please send your resume to 4531@kellyscientific.com Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer <ul class="blurbs"> <li> Location: Rocky Mount, North Carolina</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Are you someone who enjoys working in a quality role within a fast paced environment? If so, Kelly Scientific Resources is looking for you! We are working with a growing pharmaceutical company in the Eastern North Carolina for individuals that have experience with batch record review and customer complaints in a regulated industry. Our ideal candidates will possess strong organization skills, be detail orientated and will enjoy working as part of a larger team.� � Our current opportunity will be a long term contract with the opportunity for permanent placement.� This is a first shift role, Monday -- Friday. � Experience Required: - Associate's or Bachelor's Degree; or High School Diploma / GED with 4 years relevant experience - Knowledge of Batch Record Review, Customer Complaints and Sample Evaluations required - Previous experience working in a cGMP environment - Good communication, organization and computer skills - High comfort with Microsoft Office programs (Excel, Word, etc) � Primary responsibilities for this position include: - Receive, documents and begin initial investigation of batch record complaints - Conduct initial research to evaluate and determine next steps of sample evaluation and investigation - Manage the complaint process to ensure all steps are taken and completed - Maintain data and development reporting metrics for process � For immediate consideration, please utilize the following link to present your resume: <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=452140&source=Online%3A%20CareerBuilder%20Job%20Posting" rel="nofollow">Apply Now</a> � Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer � � <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=452140&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: Eastern North Carolina</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[It is an exciting career opportunity that just came available with a Fortune 500 Company for a Compliance Associate III. This is initially a 6-month contract, full-time position. Below is the full job description and qualifications. Please email your updated resume if you or any of your qualified colleagues are looking for this type of work and interested Duties: QA Compliance Specialist to assist QA Supplier Management with the following: � Participate in supplier change notification review and approval. � Participate and conduct Supplier/Material criticality assessments. � Participate and conduct Supplier/Material Annual Reviews. � To Provide strategic support to relevant Quality processes regarding Audit Management of the site. Skills: � Must have Supplier Management experience � Knowledge of Cell culture, pharmaceutical, biotechnology or vaccine industry required. � General knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry required. � Excellent communication skills, in both verbal and written form. � Ability to influence and work independently and in a team environment. � Leadership, negotiation and conflict management skills. � Change control experience necessary. � Trackwise experience desired. Education: � 3-5 years relevant experience within biotechnology/pharma/vaccine industry. Regular shift hours with occasional overtime as needed Will be required to pass a background-check and drug-screen upon hire.  <ul class="blurbs"> <li> Location: Holly Springs, NC</li> <li> Compensation: DOE</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[I am a hiring manager for a local major pharmaceutical company located in Durham NC. We are a vaccine manufacturing facility that is rapidly expanding and looking for local talent. I need 30 Bio-Process Technicians (BPT) immediately. These are all temp to perm positions. A great way to get your foot in the door! I would like to setup an informal open interview session. I plan to hold this at the local Ale House. The BPT role is an entry level position in which you actually run the vaccine manufacturing process. This is a perfect position for new graduates or the career manufacturing folks. We are primarily looking for candidates for the Virus Suite. Within this area you will have exposure to robotics in a Grade A/B area. Your primary function will be to scale up the product, inoculate with the virus and harvest the material. Full gowning is required so you must be comfortable working fully gowned from head to toe for multiple hours at a time. The position is for 12 hour shifts working the 2-2-3 schedule, day and nights. Great schedule, essentially working 7 days a week or 6 months with in the year. Requirements (Education and Previous Work Experience Required): Bachelor degree in Life Science or Engineering OR Bachelor degree and a minimum of 2 years relevant experience (working in an FDA regulated industry) OR Associates degree in Life Science or Engineering with 2 years relevant experience (working in an FDA regulated industry.) OR Associates degree with 4 years relevant experience (working in an FDA regulated industry.) OR High School Diploma or Equivalent with at least 5 years relevant experience (working in an FDA regulated industry.) If you meet these requirements and are highly motivated and willing to work please respond to this post. I am looking for people that are going to get the job done! We have a fantastic empowered culture and I need folks that are only going to add to it. If this is not you...do not contact me. I am looking to give GOOD people a GREAT opportunity. As you can imagine in a start up operation their are multiple opportunities, you only have to be willing to go after them. So the deal, if you meet the above requirements and are interested in a temp to permanent position send me your resume. I will review and if selected I will contact you. This is a tight turn around. I would like to setup interviews at the Brier Creek Ale House next week...likely Wednesday the 15th of Feb. I look forward to hearing from you!  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: 45 to 50K</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <h1>COVANCE</h1> <hr> <h2>COVANCE - Clinical Project Managers Needed - Nationwide #8</h2> <h3>Job Description:</h3> Covance is currently seeking Project Managers (all levels) These are Home-Based Positions!! Why join COVANCE in 2012? Competitive benefits Outstanding management support Variety of clinical trial projects Accelerated career growth No relocation necessary Cutting edge technology Exceptional quality of work Covance's consistent growth, size, comprehensive drug development services offerings, and geographic spread give us the opportunity to build rewarding careers. We have global operations in more than 25 countries, and more than 10,000 employees worldwide. Project Management Positions OPEN Early Clinical and Late Phase Typically under the direction of a Sr. Project Manager/Project Director, the Project Manager oversees and manages domestic, regional and/or international clinical trials. Some Responsibilities include: • Developing and managing budgets, timelines, and quality guidelines for projects • Ensuring that expectations are met while identifying and mitigating risks • Compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data Education/Qualifications: •University/college degree (life science preferred) •Working knowledge of clinical project management processes •Working knowledge of time and cost estimate development •Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs •Must be authorized to work in the US for any employer FOR A COMPLETE JOB DESCRIPTION AND TO APPLY ONLINE: www.covancecareers.com- Ref ID # 32132 Covance is an equal opportunity employer (M/F/D/V). Your privacy is important to us. <h3>About COVANCE:</h3> Covance is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.5 billion, global operations in more than 20 countries, and more than 10,000 employees worldwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/08a5bbcb" rel="nofollow">http://ziprecruiter.com/cl/08a5bbcb</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Responsibilities include, but are not limited to: Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product. Maintains, inventories, and transports all required equipment, materials, supplies and products. Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, SAP, MES, NG LIMS, HanDEL, Word, Excel) Performs housekeeping in all work areas. Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required Provides process ownership through timely actions , related to equipment supplies, required maintenance/repairs, process concerns, safety concerns, and area for improvements. Performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of sample and other materials. Performs various operations related tasks as part of an empowered team. Performs set-up and breakdown of Good Manufacturing Practice (GMP) space and equipment, operates and monitors equipment as deemed appropriate by skill level, provides materials and support needed to maintain equipment uptime, accurately and efficiently moves process materials in accordance with established procedures. Works in compliance with appropriate procedures, documentation, governmental regulations, safety programs, lean manufacturing principles and current good manufacturing practices (cGMPs). Clean Room Management/Materials Management (30% of time) � Performs tasks that require aseptic gowning. � Set-up and break down of clean room processing areas. � Move soiled equipment to equipment prep area for cleaning and/or sterilization. � Manages inventory levels in Staging Areas/Kanbans. � Moves materials throughout Durham Varicella Bulk Facility as required). � Expected to lift and move various items up to 50 lbs. � In all work follows current good manufacturing practices (cGMPs), appropriate SOPs, safety programs, good documentation practices and other governmental regulations. � Follows lean manufacturing principles. Operations Support (60% of time) � Operates and/or monitors production support equipment to include but not be limited to: Robotic Cell Culture Systems (RCCS), Wheaton Carts, shell freezers and tube welders. � Uses automated systems including MES and PLC based systems. � Proper labeling and inventory management of clean and sterile equipment using Kanbans and using the automated MES/SAP systems to set QC status and expiry of sterile equipment. � Picks-up, labels and delivers samples to appropriate sample storage locations. � May support downstream process with roller bottle manipulations Information Transfer (10% of time) � Receive training including safety, GMP, aseptic and process specific as required by the job � Detect and communicate potential safety, environmental and compliance events � Recommend improvements in equipment uptime and personnel efficiency Please note, this position requires the ability to work various shifts (evenings, overnights, weekends) Cycle is 2,2,3 (36 hours, 48 hours) 2 days on 2 days off, 2 days in 3 days off. Please note, this position will require the ability to work various shifts (evenings, overnights, weekends) Degree in Science or Engineering with 0 - 1 year experience or Candidates with no degree but 3+ years of experience will be considered. Required: Basic computer skills, including knowledge of Microsoft Office applications. Preferred: Prior experience working in a manufacturing environment. *Pay Rate: $19.23/hr. *6 month contract to hire. *If interested, please send the most updated copy of your resume. <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: $19.23/hr.</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Experienced with validation of GMP freezers and refrigerators in a Bio-Pharm environment. Write, execute and close out protocols. Background check and drug screen required. This is a contract position. Send resume for consideration. <ul class="blurbs"> <li> Location: RTP</li> <li> Compensation: Based on experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific Resources is currently seeking a food safety technician for a major food company in the Raleigh/Durham area of North Carolina. This company is a consistent leader in its field, and is highly respected for its high quality goods and scope of products and services. Candidates with experience in an FDA regulated manufacturing environment are highly desired for this great contract opportunity.  Currently there are openings on third shift with some weekend work involved.   Requirements: <ul> <li> Associate's Degree in Science or High School diploma with experience in quality, auditing, and FDA regulated manufacturing environments</li> <li> 2 years experience within an FDA regulated manufacturing facility preferred</li> <li> Working knowledge of sensory evaluation theory and methodology</li></ul>   Responsibilities: <ul> <li> Conduct laboratory testing on raw and finished materials including sensory, pH, moisture analysis, viscosity, odor, and flavor testing, among others</li> <li> Analyze data from analytical and quality testing</li> <li> Interpret QC data from use of amylographs, moisture testing, fat analyzers, and protein analysis</li> <li> Calibrate equipment and thermometers to maintain accuracy</li> <li> Maintain HACCP system policies and a safe work environment</li></ul>   For immediate consideration, please click <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=456944&source=Online%3A%20CareerBuilder%20Job%20Posting" rel="nofollow">Apply Now</a>   Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=456944&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: Cary North Carolina</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Our client located in RTP, NC has an opening for an Environmental Scientist. This is a long term contract position with the opportunity to apply for a full time position with our client.   Job Description: Qualified candidates will have a solid environmental science or environmental engineering knowledge demonstrated by completion of a BS or MS in a related field. Professional experience in environmental practice, including site characterization, remediation techniques, and surface and groundwater evaluations. Key areas of expertise and experience include: � Site Characterization. Demonstrated knowledge and skill in the use of a range of techniques used for site characterization and assessment. Experience conducting and using Phase I and Phase II assessments as specified by All Appropriate Inquiry guidelines and ASTM standards is a plus. � Environmental Data Analysis and Modeling. Demonstrated skill in the application of quality-assurance, statistical, decision-analysis, and environmental-modeling concepts and methods. � Remedial and Real Estate Redevelopment Strategies. Demonstrated skill in formulating strategies for the redevelopment of legacy industrial properties that integrate redevelopment, site cleanup, long-term stewardship, and regulatory compliance. � Data Management. Demonstrated skill in the use of environmental data management tools, visualization techniques, and related software tools for site evaluations and engineering plan development. Qualified candidates must be able to work with professionals across a wide array of disciplines that focus on complex site analysis and property redevelopment using desktop productivity tools and proprietary software tools. Qualified candidates should have a BS/MS degree in hydrogeology, geology, environmental science, or environmental engineering related to assessment and remediation of environmentally impaired industrial properties. Up to 3 years of relevant experience is a plus.  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: approximately $25 per hour but negotiable</li> <li> This is a contract job.</li> <li> This is at a non-profit organization.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Seeking a postdoctoral research fellow with in vitro (slice) patch-clamp electrophysiology experience. Work focuses on the development and function of neural circuitry underlying motivation and reward in mouse models of human neurodevelopmental disorders. Methods employed by our laboratory include in vitro electrophysiology and whole-animal behavioral pharmacology. Immunohistochemistry, design-based stereology and protein chemistry applied to support findings from our behavioral and physiological experiments. Searching for a postdoctoral level (Ph.D., M.D., D.O., D.V.M.) scientist with a strong background in slice electrophysiology who desires to learn developmental and/or behavioral pharmacology. Experience with small-animal handling (preferably mice) and patch clamp electrophysiology (preferably in acute brain slices) is essential; a strong background in dopaminergic pharmacology or basal ganglia neurobiology is highly desirable. Experience with rodent behavioral research, small-animal surgery, and/or use of the MBF StereoInvestigator software suite is desirable, but not required. Responsibilities of the position will consist primarily of patch clamp electrophysiology in acute brain slices from mouse models. Multiple techniques in behavioral pharmacology as well as unbiased stereological microscopy will also be available. Complete in vitro electrophysiology rig (fluorescence + DIC) already online and running in lab. In summary, this is an opportunity for a postdoctoral research fellow to learn developmental and behavioral neuroscience and generate a significant quantity of publishable data in a two-year period. With successful subsequent funding there are opportunities to continue this work beyond the initial two-year time frame.  <ul class="blurbs"> <li> Location: Chapel Hill</li> <li> Compensation: NIH NRSA standard scale</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[NeuroCog Trials, a rapidly growing company with close ties to Duke University Medical Center, has been involved in design and implementation of multi-site clinical trials, including rater training and data quality assurance, and neurocognitive test development, for 10 years. We are looking for a full-time project manager to lead and facilitate the life cycle of multi-site pharmaceutical company trials. These clinical trials usually involve a large meeting of investigators and testers who require certification. Travel to US or international meetings are expected. The person filling the position should be proficient in Excel and have a 4-year degree. Additional Requirements: � Lead or Co-lead for pharmaceutical companies to ensure deliverables are met at each stage throughout various project lifecycle phases. � Meet project plans and timelines. � Lead gating process for studies to ensure all policies, procedures and compliances are met and maintained electronically. � Strong Communication Skills � Lead and facilitate international communication with internal design teams and handle all change requests. � Coordinate all materials and relations on all phases of trial. We request that all interested applicants submit resume to: cmgdurham@gmail.com No phone calls, please. Applicants who call will not be considered.  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Industry Competitive </li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[NeuroCog Trials, a rapidly growing company with close ties to Duke University Medical Center, has been involved in design and implementation of multi-site clinical trials, including rater training and data quality assurance, and neurocognitive test development, for 10 years. We are looking for a full-time bi-lingual data monitor. This individual will assist in and learn neurocognitive rater certification and data quality control scoring for multi-site pharmaceutical company trials. These clinical trials usually involve a large meeting of investigators and testers who require certification. Travel to the US or international meetings are expected. The person filling the positions should be proficient in Excel, and preferably have a 4 year degree in Psychology and/or like science. Management skills are essential for growth in the position. Additional requirements: � BA in psychology, neurosciences or related field experience with neuropsychological or cognitive data collection and analysis � Ability to travel on limited basis (average 3-5 days per month) � Experience with schizophrenia, bipolar disorder, and dementia is also a plus. We request that all applicants submit resume to: cmgdurham@gmail.com No phone calls, please. Applicants who call will not be considered.  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Industry Competitive </li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Data Operations Lead NC or MA</h2> <h3>Job Description:</h3> <ol> <li> Data Operations Leader Essential Function The Data Operations Leader has overall accountability for the execution of the Data Operations strategy and the Data Operations' Technology set-up for the project. The Data Operations Leader is providing overall leadership / management for programming, data integration, data processing and statistical services on a project / program. General areas of responsibility include: coordination of the Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that the Data Operations deliverables with regard to timelines, quality, and productivity are being met. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. Relationships Reports To: (Senior) Manager, Operational Leadership Provides Work Direction to Project team members as appropriate Works Closely with All project team members External Relationships Client counterparts and management, external suppliers / vendors, auditors, investigators (if appropriate) Key Accountabilities General: Provide an extensive range of leadership and influencing capabilities to achieve the business objectives and goals for both the company and clients Effectively communicate with internal and external customers as well as third party vendors Prioritize effectively and respond to urgent requests within team or from client Participate in cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trials Coordinate technical set-up for complex projects / programs Responsible for the creation and execution of an integrated plan covering all Data Operation deliveries; this includes the coordination of dependencies between Data Operation stakeholders (Data Processing, Programming, Biostatistics) either within the company or at the client Coordinate with the Data Standards Associate and the Technology Integration Architect (if assigned), the enforcement of data standards (as appropriate for a sponsor) and the definition of the data reconciliation procedures, to decrease the need of data mapping for integrated reports such as ISE/ISS or before submission to the sponsor. Project Initiation & Planning Provide input to proposals and attend Bid Defense Meetings as required As needed, participate in a meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client Review (draft) protocol from a Data Operations perspective Attend project kick-off meetings and lead Technical Kick-Off Meeting(s) Identify and request staff necessary for the project team Be trained in client SOPs and disseminate knowledge to the Data Operation project team members, as appropriate Provide input to project tools, project plan, Central File Maintenance Plan, etc. In cooperation with the Project Leader accountable for the deliveries from the technology / data integration team (if applicable) Coordinate the set-up of the Technology platform ' in collaboration with the Data Standards Associate and Technology Integration Architect (if assigned) Ensure all team members have access to tools and documents Ensure information entered into internal management systems is accurate and updated on a regular basis Project Implementation, Control & Evaluation Coordinate Data Operations study activities Provide Leadership and direction to the project team members Provide productivity targets to the project team members Ensure the project is completed within budget, schedule, and according to contract specifications Ensure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations Ensure information entered into management systems is accurate and updated on a regular basis Use Project Plan / Data Management Plan as a management tool to record and measure progress, updating as necessary Coordinate the data quality and data integration approach ' in collaboration with the Data Standards Associate and Technology Integration Architect (if assigned) Oversee support activities for the Technology platform during study execution Early recognize areas of potential problems and provide input into contingency plans Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity Review metrics reports regularly and follow through on actions required Determine the cause of project overruns, recommend and institute corrective action, with input from functional experts, escalate and follow-up as appropriate Implement and instigate process improvements within the project Work with functional experts to track scope of ongoing work to identify CIS in a timely manner Hold team meetings on a regular basis, monitoring the progress of each individual project task, and assessing the overall status of the project. Ensure maintenance of Data Operations project documentation on an ongoing basis throughout the course of a project Oversee maintenance and completeness check of the Central File Provide performance feedback on team members as appropriate Participate in client, investigator and team meetings Prepare, participate in and follow up on audits / inspections Project Close-out: Collaborate with the Data Operations team, the Clinical Operations Leader and other functions on project close-out activities Together with PL ensure project is archived and appropriate documentation returned to the client Participate in end of study meeting and give input to lessons learned information and feedback relevant information into the function Operational Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and the company's SOPs and study specific procedures Leadership skills that include: Building and leading global (virtual) teams Ability to work effectively with and motivate virtual teams within different cultural environments Ability to negotiate and influence in order to achieve results Confidence in making decisions to achieve project timelines and quality  Ability to identify and address issues proactively Effective time management in order to meet objectives Ability to conduct root cause analysis in business problem solving and process improvement development Personal skills that include: Excellent interpersonal oral and written communication skills Ability to gain trust and confidence with a variety of clients as well as within the company Good learning ability Resilience in and ability to adjust to a rapidly changing environment Proven presentation skills Flexibility to change Ability to travel as required Commitment to quality Problem solving Good understanding and experience in the clinical trial process Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations Experience in clinical trial systems (CTMS, EDMS, EDC, IVRS, reporting tools, ..) and practical knowledge of how these applications fit and work together in the company's standard environment Understanding of the needs and use of data standards (CDISC, HL7) in the clinical trial environment Education Bachelor's degree and / or other qualification in a science or industry-related discipline Substantial experience in clinical research Demonstrated application of Project Management concepts Proven record of leading a project team in a technical/programming, data processing or statistical environment!</li> </ol> 25 % travel. Can work in NC or MA <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/da9293eb" rel="nofollow">http://ziprecruiter.com/cl/da9293eb</a></h3>  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[National Environmental company is in need of two site technicians to join their RTP team. Individual will be working at a pharmaceutical facility handling hazardous chemicals and materials for an FDA approved work site. Ideal candidate will have current 40 hour hazwoper or refresher and 5+ years experience in hazmat. Please respond to posting with resume and contact information.  <ul class="blurbs"> <li> Location: Raleigh/Durham/CH</li> <li> Compensation: Open for discussion</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Title: Clinical Trial Specialist II Department: Clinical Research Description: Conduct and facilitate specific start-up activities such as site identification, feasibilities, SRP collection, review and approval, ICF customization and approval, EC and RA submissions, as well as preparation and negotiation of Clinical Site Agreements (CSAs) on a country level with a high accountability on quality and timelines. Key Accountabilities: - Assume the ability to meet the requirements of a CTS I with a high degree of proficiency and autonomy - Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual projects - Train team members on selected tasks - Mentor and train new staff as appropriate - Action site selection strategy - Refine project-specific site selection strategy at a country level - Identify new potential Investigators and enter/update clean information into the tracking systems - Ensure feasibility, review and approval of site identification list coming from IISS - Conduct country specific feasibility and/or site pre-qualification and/or site selection activities (except for qualification visits, which will be done by CRAs) - Create country specific / site specific (if necessary) Informed Consent Form (ICF) - Review and approve country specific ICFs (if necessary) - Prepare and negotiate clinical site agreement on a country level - Prepare and submit IRB/EC application until final approval received (initial submission / Amendments) - Customize SRP Guidelines - Collect and compile regulatory documents in collaborations with the CRA and CMA - Review recruitment plan - Address/resolve issues pending from qualification visit - Address protocol questions - Check on site staff assignment - Request outstanding documents - Follow-up on appropriate site related questions - Review and approve SRP - Immediately update tracking system once regulatory documents are approved - Adapt drug label for country requirements in cooperation with Regulatory and the Logistics Team (if applicable) - Organize translations per country/regulatory/client requirements - Submit safety updates to IRB/IEC (if applicable) - Prepare and submit MOH/RA documentation and follow-up until final approval received (Initial submission/Amendments), where applicable in countries fulfilling responsibilities of regulatory services - Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC) personnel as required Skills: - Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word - Strong regulatory knowledge including GCP and local laws - Excellent interpersonal, verbal and written communication skills - Sound problem solving skills - Ability to successfully work in a 'virtual' team environment - Client focused approach to work with the ability to interact professionally within a client organization - Ability to prioritize multiple tasks and achieve project timelines - Able to take initiative and work independently - Sense of urgency in completing assigned tasks - Effective time management in order to meet daily metrics or team objectives - Shows commitment to and performs consistently high quality work - Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel) Education: Degree in a life science, nursing qualification or other relevant experience required  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: negotiable</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific Resources is currently seeking a talented, dedicated individual who is committed to working under the highest standards of integrity and ethics to produce products of excellent quality and reliability. Our client is a leader in the development and manufacture of medication delivery systems, specialty injectable pharmaceuticals, and critical care devices.  We are looking for a Microbiology Investigator in the Eastern North Carolina area. This long term contract will be Monday -- Friday, 8:00 am -- 5:00 pm with overtime as needed.   Responsibilities Include: <ul> <li> Root Cause Analysis</li> <li> Investigating, and initiating CAPA methods; when issues arise</li> <li> Working with the Microbiology groups and Senior Management to develop strategic plans</li> <li> Communicating effectively with all levels within the organization </li> <li> Must be flexible to work overtime to meet business needs</li></ul> Requirements: <ul> <li> Bachelor's Degree in a life science </li> <li> Experience with Environmental Monitoring, LAL, Endotoxin and Bioburden testing in a GMP regulated environment</li> <li> Over 2 years of CAPA and investigations experience</li> <li> GMP experience</li></ul> For immediate consideration, please click <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=456330&source=Online%3A%20CareerBuilder%20Job%20Posting" rel="nofollow">Apply Now</a>   Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=456330&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: Eastern North Carolina</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[If you need any chemicals or reagents for your research lab or institutional labs please contact me. I'm your local represents for bioabchem. For further information please visit us at www.bioabchem.com and or contact me at the e.mail link above Thank you  <ul class="blurbs"> <li> Location: North Carolina</li> <li> Compensation: N/A</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Wellington Group has been engaged to find a Subject Matter Expert in medical device manufacturing for a North Carolina based opportunity with a leading medical technologies company. Excellent opportunity to make an immediate impact with great company. The Manufacturing Director will work as a consultant helping Sr Management on the identification and utilization of Contract Manufacturers (CMO) on the scale-up of current products to large scale manufacturing for commercial use. Responsibilities include: � Work with internal and external departments, vendors and consultants on the final assembly and packaging of commercial product under GMP � Oversight of tech transfer to include troubleshooting of all design, manufacturing and packaging issues � Work with established QA department to design a vendor selection and auditing program � Establish the packaging and logistics program for all vendors and suppliers � Work with the local pilot plant, int'l suppliers and CMO on transfer to large-scale manufacturing The qualified candidate will have: � BS or MS in Science or Engineering, PhD is a plus � Experience with sterile based manufacturing is requires (aseptic and clean rooms) � Proven, hands on skills with medical device manufacturing � Contract manufacturing site start-up experience � Strong tech transfer knowledge and experience � Ability to comply with all FDA and int'l regulatory standards � Strong written and verbal communication skills � Ability to travel as required Industry: CMO, Medical Device, Contract Manufacturing, tech transfer, sterile, stent, implants, drug, pharmaceutical, pilot plant, engineering, R&D, science, clean room Job Code: 337-32-MH2322 Recruiter: Lisa Location: North Carolina Apply directly at: <a href="http://www.maxhire.net/cp/?E55E65361D43515B7D52182B77571D6D482A7E" rel="nofollow">http://www.maxhire.net/cp/?E55E65361D43515B7D52182B77571D6D482A7E</a> Don't wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( <a href="http://www.twgrecruiters.com" rel="nofollow">http://www.twgrecruiters.com</a> ) 910-338-2795  <ul class="blurbs"> <li> Compensation: DOE</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Phone calls about this job are ok.</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Wellington Group has been engaged to find an experienced Scientist with a proven background in the development of analytical methods for pharmaceutical or biological drug-based products. Excellent opportunity to make an immediate impact with great company. . .put your skills in chemistry, pharmaceuticals, and scientific analysis to work in a new role today! Responsibilities include: � Responsible for analysis and validation of all raw materials, in-process materials, final product and stability studies � Development and validation (method development and validation) of analytical methods and assays to support the drug development, product development, product characterization, product pipeline and commercialization of all products produced � Develop and write SOPs � Provide technical support and subject matter expertise, both internal and external � Work with new drug product and/or drug containing products and combined therapies � Responsible for writing scientific reports, papers and technical documents as well as supporting various regulatory filings for new products � Will work with established QA Team to ensure all procedures are completed and documented to internal company standards and that all 3rd party labs and vendors meet quality compliance The qualified candidate will have: � Proven, hands on skills with HPLC, MS, GC, LC/MS, FTIR, UV-VIS � Ability to develop, implement and troubleshoot analytical methods � Experience working with R&D and clinical research material / products � 5+ years of analytical work and scientific analysis, or pharmaceutical or drug-products or drug-containing development work, can include time in post-doc work � Strong verbal, written communication and organizational skills � Capable of managing a laboratory staff, deadlines and a budget � Knowledge of and training in GLP, GMP, and USP guidelines and regulations � BS or MS in Chemistry, PhD in Chemistry, Biochemistry or other area of scientific study is a plus Industry: Chemistry, R&D, Pharmaceutical, Biotechnology, Combination Products, Analytical Chemistry, HPLC, GLP Job Code: 341-41-MH2322 Recruiter: Lisa Location: North Carolina Apply directly at: <a href="http://www.maxhire.net/cp/?E55E68361D43515B7D52182B77571A6B482A7E" rel="nofollow">http://www.maxhire.net/cp/?E55E68361D43515B7D52182B77571A6B482A7E</a> Don't wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( <a href="http://www.twgrecruiters.com" rel="nofollow">http://www.twgrecruiters.com</a> ) 910-338-2795  <ul class="blurbs"> <li> Compensation: Great base, bonus, benefits and other perks!</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Phone calls about this job are ok.</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Quality Assurance/Compliance Manager (GMP/3rd Party Vendors) -- RTP Pharma Our client, a fast-growing pharmaceutical firm in the Raleigh area, is actively recruiting for a top-notch Quality Manager for key role on its rapidly-expanding and sharp Quality and Compliance team. Company has a diverse product portfolio: � multiple therapeutic specialties � various dosage forms � in-house and outsourced production � global production and distribution All Quality roles are extremely challenging and any successful candidate will need to be highly knowledgeable, resourceful, insightful and can-do. Company seeks an excellent candidate and will pay excellent wage to attract and retain that person. This Compliance and Quality Manager will focus on products produced by third party vendors. Reporting directly to the Senior Director of Global Quality, this Manager will be responsible for : � Managing corporate vendor management program � Performing corporate audits to ensure compliance to GMPs as well as quality standards � Writing and/or revising corporate standards and SOPs � Preparing trend reports and monitoring corrective action � Assessment and understanding of site / vendor procedures and practices � Understanding and interpreting procedures and practices in a foreign language This is a global operation with wide-reaching Operations and Quality teams. Seek a proven manager who offers a track record of succeeding in an international setting. Travel will be extensive (~50%) including a substantial international travel. Ideal candidate will offer a related degree and an impressive record of impact in a commercial pharmaceutical firm. Broad and deep knowledge of GMP standards and practices assumed and essential. Other priorities include: � Bkgd working with CMOs in a high expectations setting � Strong global experience � Broad dosage forms exposure � Regulatory inspection experience; hosting a plus � Outstanding organizational/project management skills Company is growing and seeks a QA leader to grow with them. Please forward Word resume for prompt reply. Company is not funding relo on this position.  <ul class="blurbs"> <li> Location: RTP, NC area</li> <li> Compensation: $Open$</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Engineering and Validation Division of A.N.D Consulting, Inc are seeking engineers and validation specialists to join our core team of excellence driven professionals to fill the following roles that may become available in the upcoming months and year: PROCESS ENGINEER PROJECT MANAGER EQUIPMENT VALIDATION ENGINEER/SPECIALIST CLEANING VALIDATION ENGINEER/SPECIALIST PROCESS VALIDATION ENGINEER/SPECIALIST TECH TRANSFER/START-UP ENGINEER Provide technical support to the manufacturing process including troubleshooting, debottlenecking and process optimization in a solid dosage GMP Pharmaceutical Environment. Candidates need to have strong writing skills, and a high GMP Compliance aptitude. Work closely with operators and production supervisors to monitor processes. Work on improvement projects to reduce cost and improve the efficiency of the production process. Work directly with clients, vendors, management, and technical peers to improve and or develop existing and new products Develop and improve batch records and SOPs. Demonstrate ability to solve problems and implement solutions relating to all aspects of work. Ability to drive projects to consensus and approval. SKILLS REQUIRED Professionally represents the company and division. Interacts confidently with clients, contractors, management and peers. Excellent oral and written communication skills, including effective presentation skills. Possess effective skills for developing, performing, evaluating, and/or troubleshooting PLCs and control systems (including SCADA, Delta V, and BMS systems) is a plus. Must be hands-on and field experienced. Proficient in Microsoft Word, Excel, Power Point and Project. With a strong knowledge of solid dosage. JOB REQUIREMENTS BS in Engineering or Life Sciences (Chemical Engineering preferred). Must be hands on and field experience. Minimum 3 years industry experience in a GMP manufacturing environment. This position is based in Durham, NC but you must be willing to travel locally, nationally or internationally. COMPANY INFORMATION The Engineering and Validation Division of A.N.D. Consulting, Inc. provides Consultation Services to Pharmaceutical and Biotech companies within the global market. Our services include: Project Management System Design Commissioning/Start-Up Master Plan Development Equipment Qualification Automation and Control System Qualification Cleaning Validation Writing and Execution of Validation Protocols Process Validation Process Studies Quality Assurance Services We expect our consultants to be professional and get the job done in an effective AND efficient manner with minimal guidance and supervision. We expect our consultants to excel at their work, By working hard, being diligent, asking the right questions, meeting project deadlines, and exceeding client expectations. While being honest, having integrity, taking personal responsibility and having respect for people.  <ul class="blurbs"> <li> Location: Nc.</li> <li> Compensation: nego</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The QA Associate will conducts assays to performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples, package samples and components. Responsibilities: Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Company standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Learns to recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Analyzes Results- Accountable for the accuracy and validity of testing results. Performs mathematical calculations, interprets results, records observations. May utilize Laboratory Information Management Systems. Lab Support- Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. SOP's and Administration- Learns to analyze and interpret project/study/investigation results and findings. Learns to determine next steps under guidance of supervisor and in compliance with applicable regulations. Carries out technical and administrative duties as assigned. Contributed to design of new studies in consultation with supervisor. Prioritization: Receives overall project direction from supervisor periodically and carries out most projects/studies/reviews/investigations without supervision. Consults with supervisor at the start and completion of new initiatives/assignments. Qualifications: Incumbent has a basic knowledge of fundamental technical and quality concepts and receives daily supervision. B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline. With a B.S., more than two years of relevant Quality experience preferably in the bio/pharmaceutical industry. Knowledge of regulations and procedures: Is aware of new methodologies pertinent to the Quality function area and is able to introduce them with supervisory input. Analytical Techniques and Methods: has mastered most or all of the fundamental technologies, as well as some specialized technologies and relevant analytical techniques. Documentation and Systems Use: Ability to interpret and document test results according to standard operating procedures using all standard Quality systems. Must have a strong background using LIMS. Advancing Methods: Analyzes and interprets many project/study/investigation results. Makes limited decision on issues and informs supervisor of action taken. Teamwork: Ability to lead teams comprised of immediate group member or to work cross functionally. Skills: Good laboratory Practices (GLP) Good Manufacturing Practices (GMP), Quality Control, Laboratory Information Management systems (LIMS) Reading Plates, Water Sampling/Testing  <ul class="blurbs"> <li> Location: Sanford, NC</li> <li> Compensation: .</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[POSITION SUMMARY: Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, and approved license requirements. Results are compared with specifications and documented. Must have a basic knowledge of fundamental technical and quality concepts and receives daily supervision. RESPONSIBILITIES: Conducts Assasys- Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Learns to recognize atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Analyzes Results- Accountable for the accuracy and validity of testing results. Performs mathematical calculations, interprets results, records observations. May utilize Laboratory Information Management Systems. Lab Support- Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. SOP's and Administration- Learns to analyze and interpret project/study/investigation results and findings. Learns to determine next steps under guidance of supervisor and in compliance with applicable regulations; carries out technical and administrative duties as assigned. EDUCATION AND EXPERIENCE: B.S. in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline. With a B.S., 2+ years of relevant Quality experience preferably in the bio/pharmaceutical industry. TECHNICAL SKILLS: Knowledge of regulations & procedures: Is aware of new methodologies pertinent to the Quality function area and is able to introduce them with supervisory input. Analytical Techniques & Methods: has mastered most or all of the fundamental technologies, as well as some specialized technologies and relevant analytical techniques Documentation & Systems Use: Ability to interpret and document test results according to standard operating procedures using all standard Quality systems; strong background using LIMS Advancing Methods: Analyzes and interprets many project/study/investigation results. Makes limited decision on issues and informs supervisor of action taken. Contributed to design of new studies in consultation with supervisor Prioritization: Receives overall project direction from supervisor periodically and carries out most projects/studies/reviews/investigations without supervision. Consults with supervisor at the start and completion of new initiatives/assignments. Teamwork: Ability to lead teams comprised of immediate group member or to work cross functionally REQUIRED SKILLS: - Good Laboratory Practices (GLP) - Good Manufacturing Practices (GMP) - Quality Control - Laboratory Information Management Systems (LIMS) - Water Sampling/ Testing <ul class="blurbs"> <li> Location: Sanford</li> <li> Compensation: DOE $18-$25/hour W2 basis</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[We are looking for an experienced Data Manager/Scientist to work with a pharmaceutical client in RTP. Candidates must have experience working on HIV clinical trial studies, SAS programming and data management. PRIMARY RESPONSIBILITIES INCLUDES: -Tracking and processing data for HIV clinical studies -Interacting with clinical, monitoring and other data management, and scientific staff -Raising, issuing and resolution of data queries -Liaison with statistics, clinical and data management to resolve queries -Maintenance of data management databases. -Managing activities from data entry to data clean up and analysis. -This will be performed using various online database accesses and excel and other programs as needed. REQUIREMENTS Experience with relational databases and/or SAS programming and other programming skills is valuable. Detail - oriented and ability to work to timelines and quality standards is critical. Expert organizational skills and experience in handling data inconsistencies. Require patience and ability to retain high standards when working to tight timelines PLEASE SUBMIT RESUMES IF YOU MEET THE REQUIREMENTS FOR THIS POSIITON <ul class="blurbs"> <li> Location: RTP</li> <li> Compensation: 40-50 an hr</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific Resources is working with a medical device company in the Research Triangle Park area to find an Analytical Scientist with method development experience to join their expanding team.� This opportunity is for a first shift long term contract beginning immediately.� � Requirements: <ul> <li> BS/MS in Chemistry or closely related field and a minimum of 5+ years pharmaceutical or drug delivering medical device experience</li> <li> Experience in analysis of active pharmaceutical ingredients and their degradation compounds using HPLC, Mass Spec, IR, and UV-Vis</li></ul> � Duties: <ul> <li> Develops and conducts testing of active pharmaceutical ingredients using HPLC, Mass Spec, IR, UV-Vis and other analytical methods</li> <li> Performs analytical chemistry research and development of assays in collaboration with others</li> <li> Assists in developing and validating testing methodology used to control raw materials, production intermediates and final products</li> <li> Conduct investigation and developmental testing of samples to provide analytical support of R&D activities</li> <li> Writes SOPs, protocols, reports, and other documents as needed</li></ul> Qualified candidates are encourged to use the following link for immediate consideration: <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=443201&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: hourly</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[DESCRIPTION: Growing Mechanical, Engineering, and Environmental Company Needs Technicians, Installers, and Service Team for Installation and Maintenance of Air Improvement Systems. Applicants Must Have Basic Plumbing and Electrical Skills as well as General Construction Knowledge. Earn $35,000 to $55,000 per Year + Benefits. This is A Great Opportunity for a Long-Term Career with Plenty of Potential for Advancement with a Growing Company! These are Full-Time Positions that may Require Some Overtime and In-State Travel. TO APPLY FOR THIS POSITION, PRELIMINARY TESTING IS REQUIRED. CLICK ON OR COPY AND PASTE LINK BELOW TO START THE TESTING AND UPLOAD RESUME. <a href="http://www.ondemandassessment.com/verify/apply/mRDRvR/DDDnhbh" rel="nofollow">http://www.ondemandassessment.com/verify/apply/mRDRvR/DDDnhbh</a>  <ul class="blurbs"> <li> Location: Winston/Salem/Greenboro/Raleigh</li> <li> Compensation: $35,000 to $55,000+ per year plus bonuses & benefits</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Description: *6 month contract assignment in Wilson, NC. Candidate must pass drug test and background screening prior to starting* Performs USP microbiological method testing such as Bacterial Endotoxin, Sterility and Biological Indicators. Performs environmental monitoring of a cGMP facility. Performs routine testing of a water system. Responsible for analysis of raw materials, in-process bulk, finished products, stability samples, and validation samples with minimal supervision. Performs other duties and responsibilities as assigned by supervisor Requirements: *Associate Degree or Four-year college degree in Microbiology, Biology, Biochemistry or related field required. At least one year of laboratory experience in support of manufacturing. *Thorough knowledge and hands-on experience on microbiology testing. Knowledge and experience with USP *Microbiological methods. *Familiar with aseptic techniques. *Knowledge of cGMP, cGLP, and FDA regulations. *Understanding of quality control processes. *Good organizational, interpersonal, written and oral communication skills. *Ability to meet and monitor deadlines and prioritize work. *Self-motivated and detail oriented. *Computer skills including Microsoft Office Suite. *Flexible ability to take on additional tasks as needed.  <ul class="blurbs"> <li> Location: Wilson, NC</li> <li> Compensation: $13-$18 an hour</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Help needed to execute searches of existing patents for relevance in areas of clinical trials and computer sciences. Background helpful in these areas, we can show you how to do this but background in these areas is helpful as majority are not relevant. You will divide results into non-, potentially, and likely relevant categories for higher-level internal review. Must sign confidentiality agreement. Flexible as to where and when work is done.  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Commensurate with background and skill level.</li> <li> Telecommuting is ok.</li> <li> This is a part-time job.</li> <li> This is a contract job.</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Seeking OB/ Gyn with 5 years practice (or educational) experience to drive clinical studies. Needs experience working with, or in, clinical trials to develop strategy for both pre and post market. Description: The Director, Medical Affairs, Women's Health will impact women's health worldwide through the development, clinical validation and documentation of novel products. This position will lead the Medical Affairs function and define the clinical value proposition from both the patient and clinician viewpoints. The person in this roll will develop, maintain and leverage a broad global network of Key Opinion Leaders (KOL) to ensure relevant clinical input into the product development strategy. They will also design, execute and submit PMA studies to the Clinical Operations Group. Principle Responsibilities: Facilitate interactions with KOLs and community based clinicians to identify unmet clinical needs and to discuss product concepts related to the improvement of cancer detection and diagnoses of other women's diseases. Translates these clinical needs to product requirements in conjunction with the CSO and R&D leadership, as well as product development teams. Continuously seek to extend network of KOL contacts and influence to regions outside the US as well. Collaborate with global Medical Affairs personnel and regional health authorities. Responsible for the medical content of the clinical value proposition for products which includes an assessment of the medical economic impact of marketed and pipeline products. Provide clinical expertise and insight to multi-function project teams. Work closely with the Chief Scientific Officer to direct the activities of the Scientific Affairs personnel to facilitate the development of KOLs as well as to assist in the management of external clinical trial collaborations for both preclinical evaluation and post-launch studies to monitor for product effectiveness and intended use performance. Proactively seek out new technologies and methods relevant to the mission of Women's Health and Cancer . Work closely with the Chief Scientific Officer and R&D leadership to see that new technologies and product development activities address unmet clinical needs. Perform health hazard evaluations on any product having a quality or performance issue to appropriately participate in any field action regarding product safety or performance. QUALIFICATIONS: � Medical Degree and Board Certification as an OB/GYN � Minimum of 5 years in clinical practice � Previous experience in clinical protocol design � Previous experience in industry Medical Affairs function or public health/epidemiology background preferred � Previous experience in an academic background and a demonstrated commitment to women's health preferred � Previous management experience � Expert on management, designing clinical trials, create advocates in the community, US and beyond � Strong communications skills and personality fit to work with regulatory, marketing and business leadership � Analytical skills - able to combine practical, clinical knowledge with analytics/statistics to provide guidance on the design and execution of clinical studies � Strong influence management skills - able to present compelling messages to influence customers, government regulatory agencies and other key stakeholders COMPANY OFFERS: � Base salary + generous bonus � 401K Match -- company matches 75% up to 6% of base salary � Pension Plan - cash out plan - 3 year vesting period � 3 weeks paid vacation � 12 paid holidays � Benefits from day one of employment Must reside in the Raleigh/Durham, NC area. No relocation available at this time. Please contact me through LinkedIn if you are interested in the position.  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Generous + Good Benefits</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Summary: Cytonet LLC, a company specializing in the manufacturing of primary liver cells for cell therapy applications in the US and Europe in the field of cellular and biological therapeutics is seeking a Production Scientist. Essential Functions:  Production of human primary cell using accompanying documentation according to GMP guidelines.  Implementation of in-process quality control tests on human primary cells.  Maintenance and cleaning of equipment.  Calibration and qualification of equipment.  Maintenance of clean room areas and environmental monitoring.  Reviewing, revising, and writing of operating protocols, reports and SOPs according to GMP guidelines.  Reviewing, writing and execution of process validations for the production of human primary cells.  Maintenance of documentation and logbooks.  Must be able to work in a clean room environment with Personal Protective Equipment (confined area) *** Must be able to work a flexible on-call schedule including weekends and holidays*** Qualifications:  BS in science or a related field.  0-3 years experience in a FDA and/or EU GMP regulated environment  Working knowledge of FDA and EU manufacturing/regulatory quality systems regulations, qualification and validation and facilities requirements  Experience working in a clean room environment or biological containment facility  Experience working with tissue/primary cells is ideal  Knowledge of aseptic technique  Ability to read and follow Standard Operating Procedures  Must possess strong motivational skills and be able to work in a team environment.  Must be detailed oriented and have excellent organizational skills  Must possess effective written and oral communication skills  Must be able to work in multi-faceted operation  Experience with Microsoft Word, Excel and Outlook.  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: Based on experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Candidate will be supporting a Drug Safety Group by managing their project data. Will be working in fast paced environment and therefore needs to be comfortable multi-tasking and have excellent time management skills. No clinical research experience is needed as there will be on the job training, but candidate must be interested in the clinical research field. It is also required that canidadates also have a Bachelors Degree in the Life Science fields.  <ul class="blurbs"> <li> Location: RTP</li> <li> Compensation: $13.38</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Clinical Trial Specialist ll</h2> <h3>Job Description:</h3> Clinical Trial Specialist II Department: Clinical Research Description: Requirements: - Prepare and submit Institutional Review Board (IRB)/Ethics Committee (EC) applications until final approval received (initial submission / Amendments) - Customize SRP Guidelines - Collect and compile regulatory documents in collaborations with the CRA - On a regular basis conduct outbound and receive inbound calls to: - Review recruitment plan address/resolve issues pending from qualification visit address protocol questions check on site staff assignment request outstanding documents - Follow-up on appropriate site related questions - Review and approve SRP - Immediately update tracking system once regulatory documents are approved - Adapt drug label for country requirements in cooperation with Regulatory and the Logistics team (if applicable) - Organize translations per country/regulatory/client requirements - Submit safety updates to IRB/IEC (if applicable) - Prepare and submit MOH/RA documentation and follow-up until final approval received (Initial Submission/Amendments), where applicable in countries fulfilling responsibilities of regulatory services - Assist with QC/audit of central files and liaise with Research Regulatory Compliance (RRC) personnel as required - Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual projects - Train team members on selected tasks - Mentor and train new staff as appropriate - Action site selection strategy - Refine project-specific site selection strategy at a country level - Identify new potential Investigators and enter/update clean information into the tracking systems - Ensure feasibility, review and approval of site identification list coming from FCI - Conduct country specific feasibility and/or site pre- qualification and/or or remote qualification visits and/or site selection activities (except for on-site qualification visits, which will be done by CRAs) - Create country specific / site specific (if necessary) Informed Consent Form (ICF) - Review and approve country specific ICFs (if necessary) - Prepare and negotiate clinical site agreement at a site level Experience: Experience: - Degree in a life science, nursing qualification or other relevant experience required Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word - Strong regulatory knowledge including GCP and local laws - Excellent interpersonal, verbal and written communication skills - Sound problem solving skills - Ability to successfully work in a 'virtual' team environment - Client focused approach to work with the ability to interact professionally within a client organization - Ability to prioritize multiple tasks and achieve project timelines - Able to take initiative and work independently - Sense of urgency in completing assigned tasks - Effective time management in order to meet daily metrics or team objectives - Shows commitment to and performs consistently high quality work - Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel) Education: Degree in a life science, nursing qualification or other relevant experience required   <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/f2548a1a" rel="nofollow">http://ziprecruiter.com/cl/f2548a1a</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/a1f1f0ee.jpg"> <h1>ProPharma Group</h1> <hr> <h2>Quality Assurance - Contract - NC</h2> <h3>Job Description:</h3> Responsibilities: •5+ years experience in Quality Assurance type role within Pharmaceutical, Biotoechnology or Medical Device industries. •Working knowledge of Quality Systems, GMPs, SOPs, batch review/disposition, review/approval of investigations, review/approval of CAPA, and review/approval of change control. •Strong technical writing skills associated to SOP development, CAPA, change control, and investigations. •Extensive travel required. EDUCATION REQUIREMENTS •B.S. /B.A in Scientific discipline (Engineering, Chemistry, Biology, Microbiology or related life science) Must be authorized to work in the United States. For consideration, please submit resumes to careers@propharmagroup.com or visit our website at <a href="http://www.propharmagroup.com/Careers.aspx" rel="nofollow">http://www.propharmagroup.com/Careers.aspx</a>. <h3>About ProPharma Group:</h3> ProPharma Group, a national company, serves the qualification, compliance and technical service needs of clients in the pharmaceutical, biotechnology and medical device industries. Our validation professionals include chemical, electrical, mechanical and computer engineers, chemists, microbiologists and other specialists. ProPharma Group provides an excellent work environment and a culture of experience, integrity, and commitment. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/dfff3bdd" rel="nofollow">http://ziprecruiter.com/cl/dfff3bdd</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific Resources is currently seeking a talented, dedicated individual who is committed to working under the highest standards of integrity and ethics to produce products of excellent quality and reliability. Our client is a leader in the development and manufacture of medication delivery systems, specialty injectable pharmaceuticals, and critical care devices.  This first shift position is going to be a long term contract with the opportunity for permanent placement.   Requirements: <ul> <li> Bachelor's Degree in a life science </li> <li> 3 -- 5 years experience with CAPA, deviations, OOS, OOT, non-conformances</li> <li> Experience with analytical testing in a research setting</li> <li> GMP experience</li></ul>   Responsibilities Include: <ul> <li> Investigating, and initiating CAPA methods</li> <li> Root Cause Analysis</li> <li> Assist in the research lab with projects as need arise</li> <li> Working with Laboratories, Manufacturing and Senior Management to develop strategic plans</li> <li> Communicating effectively with all levels within the organization </li> <li> Must be flexible to work overtime to meet business needs</li></ul>   For immediate consideration, please click <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=451178&source=Online%3A%20CareerBuilder%20Job%20Posting" rel="nofollow">Apply Now</a>    Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer.   <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=451178&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: Clayton, North Carolina</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[We are actively seeking an entry-level Lab Technician for a 2nd shift position in RTP. Hours are Sunday - Thursday, 3pm-11:30pm. In this role, you will be responsible for running molecular genetics assays involving PCR, gel electrophoresis, DNA extraction and other lab responsibilities as assigned. Requirements: � BA/BS degree in Biology, Chemistry or related life science is required. � Must be able to provide transcripts upon request. � Moderate physical effort (up to 30 pounds) is required. For immediate consideration, please email a MS Word resume. If contacted, must be able to provide transcripts ASAP.  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: $15.00/hr + medical, dental, life, vision insurance, 401K, stock options and mor</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[On-Call Tissue Processing Technician (Part-time/Weekends) -- Top $$ Seeking skilled and experienced tissue processing technician for on-call work with RTP biotech firm. Company is performing breakthrough research in the field of regenerative medicine. They use donated tissue for research. Tissue availability is sporadic and unpredictable. They seek a candidate who will be available off hours (evenings/weekends) to accept the tissue and process the cells in their lab. Company will pay an excellent wage for a reliable and skilled professional who is interested in taking on this on-call commitment. Details. . .. . . � Some training is available. Bkgd with aseptic technique and working with cell isolation, cell culture or tissues is required. � Demonstrated ability to, with limited direction/supervision, consistently follow directions via SOP, email, or verbal communications will be essential. � Experience working with and adhering to GMP/GLP documentation standards required � On call needs are expected ~ 3 times per week -- but will vary. Company will guarantee minimum hours. If this role would be of interest to you, please forward Word resume or CV. Local candidates only. No visa sponsorship available.  <ul class="blurbs"> <li> Location: RTP, NC area</li> <li> Compensation: $Open$</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[We have an urgent requirement for Production Technician to work at one of the world's largest companies, located in DURHAM NC, 27712 . Please go through the job description and if you find it interesting then please send me an updated copy of your resume. Position: Production Technician Location: DURHAM NC 27712 Duration: 6+ Months Qualifications: The Production Technician is an excellent entry level opportunity for recent university graduates as well as experienced individuals that are interested in a hands on opportunity to manufacture vaccines. The individual in this position will support the manufacturing process through hands on cell culture and purification activities as well as other production related activities. Candidates with Associates degree must have 5 years experience, most of which is within a clean room (aseptic) environment including multiple years in pharma. Key responsibilities for the Production Technician include aseptic practice and GMP (Good Manufacturing Practices) adherence, working in a team environment to accomplish departmental goals, as well as the ability to direct your own work through leadership. Schedule Cycle is 2,2,3 (44 hours, 36 hours, 40 hours); 2 days on 2 days off, 2 days in 3 days off. Please note, this position requires the ability to work various shifts (evenings, overnights, weekends). Preferred: Prior experience working in a manufacturing environment Responsibilities: Responsibilities include, but are not limited to: Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product. Maintains, inventories, and transports all required equipment, materials, supplies and products. Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, SAP, MES, NG LIMS, HanDEL, Word, Excel) Performs housekeeping in all work areas. Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required Provides process ownership through timely actions , related to equipment supplies, required maintenance/repairs, process concerns, safety concerns, and area for improvements. Performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of sample and other material.  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: Based on experience</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Description: ***SECOND SHIFT POSITION** 3:30PM-12:AM *Candidates cannot begin an assignment without successful drug & background clearances. *1 year contract assignment in Wilson, NC. Tests and interprets results for raw materials, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples. Interprets compendial and internal monographs, NDAs and Laboratory Quality Standards. Requirements: BS/MS in science, preferably in Chemistry or Biology, with 2 or more years of pharmaceutical laboratory experience. Basic knowledge of analytical instrumentation with strong technical and interpersonal skills. Strong working knowledge of raw materials, KF, Dissolution, HPLCs(Waters) is preferred  <ul class="blurbs"> <li> Location: Wilson, NC</li> <li> Compensation: $20.40</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <h1>CCI</h1> <hr> <h2>Medical Device Rep</h2> <h3>Job Description:</h3> Leading Medical company seeks an outside sales rep. to call on accts in the assigned territory. Candidates will be responsible for cold calling, contract implementation and inservice. Limited travel, great corp. culture and solid Intl. co. Candidates need only apply if you meet the following criteria: 4 year degree 2+ years of b2b experience with a leading co (IKON, Newell, ADP). Pharm background will only be considered if prior b2b - non pod Documentation of sales exp. Rankings - awards a must Strong business acumen No more than two jobs post grad PLEASE DO NOT APPLY IF YOU DO NOT MATCH THE CRITERIA SET BY THE HIRING CO. THANKS <h3>About CCI:</h3> Fortune 100 company Fast track to mgt Market leader <h3>Apply Now: <a href="http://ziprecruiter.com/cl/1c1f993a" rel="nofollow">http://ziprecruiter.com/cl/1c1f993a</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Experienced Clinical Research Coordinator EXPERIENCED CRC NEEDED. Minimum of 2 to 3 years of experience coordinating Clinical Trials at an investigational site. Research facility in Raleigh, NC is currently seeking experienced Clinical Research Coordinator. Successful candidate will demonstrate knowledge of study protocol by adherence to study guidelines. Incumbent will be responsible for supporting and conducting research for assigned study protocols and careful monitoring of research participants and procedures under principal investigator guidance to include: � Screening and interviewing potential study participants. � Planning, scheduling, and executing day-to-day research activities � Maintaining case report forms, charts and documentation. � Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Minimum qualifications include excellent communication and organizational skills; detail-oriented; strong interpersonal skills; and decent computer skills. Ability to perform phlebotomy and other clinical functions a must. MUST have 2 to 3 years of experience coordinating Clinical Trials at an investigational site. Medical/clinical background or a bachelor's degree in a medically related field or nursing licensure, including LPN, desired. Medical assistant certifications will be considered. Please send resume and salary requirements via email.  <ul class="blurbs"> <li> Location: Raleigh, NC</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[A Triad-based pharmaceutical firm with multiple marketed products as well as a substantial pipeline, is actively recruiting for a highly skilled and knowledgeable Production Supervisor to assist during evening shift hours. The Production Supervisor will direct/maintain workflow and manage the evening operations of production areas. Some key areas of responsibilities include: � maintain work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; � monitor personnel and resources; � study methods; implement cost reductions; develop reporting procedures and systems; facilitating corrections to malfunctions within process control points; � Create and revise systems, batch paperwork, and procedures and implement change and improvements where needed. � train operators/line leaders in GMP, SOP, and Safety compliance, as appropriate In addition to core skills (4 yr. degree and 2+ years of directly related experience), client seeks a high energy and focused Production Supervisor who anticipates, collaborates and communicates. This is a Direct Hire opportunity and an immediate need. Many more details are available...please email your detailed resume for immediate consideration.  <ul class="blurbs"> <li> Location: Triad NC</li> <li> Compensation: doe</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[A Raleigh-area biotech firm with multiple pipelined products as well as partnerships with larger players in the drug and device markets, is actively recruiting for an Analytical Scientist to join its growing team on a long-term contract basis. The Sr. Analytical Scientist will be responsible for assisting with the following tasks in a cGMP environment: � Develops and conducts testing of API by HPLC, Mass Spec. and other analytical methods � Performs analytical chemistry research and/or development to develop assays based on new and existing methodologies � Method development / method improvement work including developing and validating testing methodology used to control raw materials, production intermediates, and final products � Executing testing scripts that are part of analytical software validation. Company uses Chemstation � Helps establish, validate and document new or existing compound identification methods � Coordinates analytical activities performed by outside laboratories, vendors, and collaborators � Writes SOPs, protocols and reports and other quality documents as needed Along with a Ph.D in Chemistry or related field, qualified candidates will have 3+ years of experience in similar lab settings with particular bkgd in the Method Development, analysis of API (Active Pharmaceutical Ingredients) and their degradation compounds. In addition, candidate must be experienced with various analytical techniques including MS, HPLC, GC (FID, MSD), LC-MS, FTIR, UV/VIS, Microscopy as well as some knowledge of ChemStation. This client is experiencing tremendous growth, and seeks a Sr. Analytical Scientist who can assist with the increased demands. This position is structured as a long- term contract and is an immediate need.  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: hourly</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[DESCRIPTION The Patient Care Advocate (PCA) will help those with complex medical conditions manage their drug therapy. The PCA will work with patients, physicians, and third party payors to facilitate and expedite patient access to needed medications. Activities will include data entry for prescription fulfillment, managing prior authorizations, researching payment options, assisting patients with questions and delivery preferences, and making refill reminder calls. PCA's are required to become Certified Pharmacy Technicians within six months of hire. DUTIES Responsibilities of all employees: �Represent the Company professionally at all times through care delivered and/or services provided to all clients. �Comply with all State, federal and local government regulations, maintaining a strong position against fraud and abuse. �Comply with Company policies, procedures and standard practices. �Observe the Company's health, safety and security practices. �Maintain the confidentiality of patients, families, colleagues and other sensitive situations within the Company. �Use resources in a fiscally responsible manner. �Promote the Company through participation in community and professional organizations. �Participate proactively in improving performance at the organizational, departmental and individual levels. �Improve own professional knowledge and skill level. �Advance electronic media skills. �Support Company research and educational activities. �Share expertise with co-workers both formally and informally. �Participate in Quality Assessment and Performance Improvement activities as appropriate for the position. QUALIFICATIONS Requirements: �High School Diploma or equivalent/college degree preferred �Experience working with pharmacy benefits a plus �Proficient with PC applications (esp. Microsoft Office) �Bilingual capability would be a plus �Experience with an electronic medical record or pharmacy software, CPR+-specific experience a plus �Successful candidate must become certified Pharmacy Technician with 6 months of hire Essential Qualities: �Exceptional customer service and verbal/written communication skills � Must possess a positive attitude and be solutions-focused �Ability to work independently in a fast paced team environment �Must be flexible and adaptable, bringing a high level of creativity and resourcefulness �Conscientious with exceptional attention to detail �Excellent organizational and time management skills �Must excel at simultaneously managing multiple priorities Hours: �This is a full-time position with day shift hours generally Monday through Friday. Some overtime may be required. For more information, or to apply now, you must go to the website below. Please do not email your resume to us as we only accept applications through our website. <a href="http://kerrdrugjobs.iapplicants.com/ViewJob-171225.html" rel="nofollow">http://kerrdrugjobs.iapplicants.com/ViewJob-171225.html</a>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: .</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[<a href="http://jobs.syngenta.com/job/Rearch-Triangle-Park-Regulatory-Affairs-Specialist-Job-NC/1700399/" target="_blank" rel="nofollow">Click here to apply for this Regulatory Affairs Specialist Job (Rearch Triangle Park, NC, US)</a> Research Triangle Park, NC, US Division: Regulatory Affairs Function: Seeds R&D Quality Management City: Research Triangle Park, Durham State/Province: North Carolina [NC] Country: United States [US] Position Title: Regulatory Affairs Specialist Job ID: 2783 Role Purpose/Accountabilities: 1) To drive the regulatory work-stream for biotechnology products by significant engagement in regulatory sub-teams including role of sub-team lead as appropriate 2) To support the regulatory team in designated areas of expertise (e.g. project planning and tools, document and record management, review of protocols and reports) 3) Serve as a subject matter specialist in an area of expertise Accountabilities: - Serve as a source of expertise and support in a particular subject area - Active engagement in subteam meetings representing subject areas as appropriate - Manage own workslate - Participate in the development of new process - Provide input on design and reporting of studies for use in regulatory dossiers - Commitment to developing an indepth knowledge of biotech regulatory requirements - Provide technical support to Syngenta regulatory colleagues in other world areas seeking similar approvals - Manage and provide advise on tools and process used within RA - Active engagement in development opportunities Knowledge, Skills & Experience: Critical knowledge: Minimum bachelors degree or equivalent experience in a relevant field (e.g. molecular biology, biochemistry, toxicology, entomology, plant breeding, etc.) - Cursory knowledge of a broad range of scientific disciplines including: molecular biology, plant molecular biology, general agricultural science; familiarity with plant breeding and agricultural production desired Critical experience: - Two to five years work experience in plant biotechnology regulatory affairs, through prior position in industry, academia, or government institution - Experience in the interpretation and communication of results from biological experiments - Experience in conducting and defending weight of evidence evaluations Critical technical, professional and personal capabilities: - Effective writing skills, especially technical writing (e.g., scientific papers, progress or technical reports, fellowship or grant proposals, writing courses, etc) - Demonstrated ability to work successfully on cross functional teams to ensure proper study design and execution, and to support critical and timely decision-making - Analytical and problem solving skills - Demonstrated successful organizational skills and strong attention to details - Project management experience and committment to further development - Relationship management skills with the ability to successfully influence others - Construction of and adherence to realistic timelines - Ability to deal with organizational complexity and ambiguity Additional Information: - All applicants must be eligible to work in the US. <ul class="blurbs"> <li> Location: Research Triangle Park, Durham, NC</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific Resources is currently seeking Research Technicians.  Our client is located on a local university campus, and is actively seeking research technicians with tissue culture experience.  This opportunity is a contract position, with the potential for long-term opportunities. Successful candidates will possess a strong work ethic and the ability to work well in a team environment.   Experience Required: <ul> <li> Bachelor's Degree in a life science or related field</li> <li> 1 - 3 Years of Experience</li> <li> Experience with tissue cultures is a must</li></ul>   Duties and Responsibilities Include: <ul> <li> Mammalian tissue culture</li> <li> Dissection of tissue samples from rats and mice</li> <li> Plasmid preparation, cloning, PCR and genotyping</li> <li> Helping to dispense reagents and create solutions; as well as, ordering supplies and maintaining the cleanliness of the laboratory</li> <li> Maintaining a detailed laboratory notebook</li></ul>   Qualified candidates are encouraged to apply for immediate consideration using the following link: <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=454192&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: Hourly</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/fce907be.jpg"> <h1>The Fountain Group</h1> <hr> <h2>Quality Manufacturing Auditor</h2> <h3>Job Description:</h3> Contract opportunity with a prominent client for a Manufacturing Auditor in Wilson, NC. 6 Months 4 Positions This position is responsible for performing audits of the manufacturing process to cGMP's and Quality Systems. Using various data steams including: SOP's, Policies, Deviations, CAPA's, and Change Control Systems, perform a Gap Analysis of current operations and develop action plans to mitigate any gaps. Responsibilities: Perform Audits of Dispensing, Granulation, Compression, Coating and Packaging Areas and document results in an audit summary report. Perform Gap analysis of current operations to cGMP's, and Quality Systems. Develop action plans to mitigate and participate in the completion of any action plans. Qualifications: Must have ability to perform manufacturing audits with minimal supervision. Must have ability to drive results and monitor completion of action items developed from audit. Adherence to all health, safety and environmental regulations in support of departmental and site HSE goals. Work in a safe and efficient manner. Education and Experience: Bachelor's degree in a scientific/technical field with 5+ pharmaceutical industry experience in manufacturing auditing. Auditing certification is preferred. For immediate consideration, please forward a current copy of your Word formatted resume. <h3>About The Fountain Group:</h3> The Fountain Group was founded in 2001 with the mission of providing quality resources to businesses on a contingent basis and has been providing quality individuals to National Fortune 100 and 500 companies ever since. The Fountain Group steadily increased its presence over the years and is now recognized as a leading resource provider throughout various industries and MSP programs. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/71a229df" rel="nofollow">http://ziprecruiter.com/cl/71a229df</a></h3>  <ul class="blurbs"> <li> Location: Wilson</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[This job is located in Portland, Oregon! HemCon Medical Technologies, Inc. was built on a simple premise -- to save lives. Our success path started with life-saving hemostatic solutions and has grown to encompass a variety of innovative technologies and solutions to move medical products forward and improve patient care. HemCon is seeking an experienced Clinical Data Manager to assume the overall responsibility for the quality and timeliness of all data management activities to ensure the completeness and validity of the clinical trial database. The Clinical Data Manager must: � Develop standard operating procedures and CRF/eCRFs for data collection and management. � Conduct data entry, data validation, query management, adverse event and SAE reconciliations. � Develop data management plans. � Perform software validation. � Perform data analysis for studies, including statistical analyses and demographic summaries. � Resolve data audit issues with CRAs and/or clinical sites. � Prepare clinical summaries for regulatory submissions. Requirements: � Bachelor's degree in science related field. � Knowledge of GCP, regulatory and ICH guidelines, CDM systems, and Part 11 compliance. � Demonstrated ability to manage clinical trial data from study inception through submission to FDA. � Three to eight years' experience working in an FDA-regulated environment with database administration and data reduction techniques; project management experience is helpful. � Computer proficiency with Microsoft Office software; extensive database experience, including layout design, relational database system, and open database connectivity. � Excellent time management / multi tasking skills. � Ability to work independently, with good collaboration skills. � Outstanding verbal and written (including technical) communication skills. HemCon offers a friendly, progressive work atmosphere and a comprehensive compensation and benefits package. HemCon is an Equal Opportunity Employer. Please send cover letter with wage requirements and resume to Recruiting@hemcon.com. Please visit our web page at www.hemcon.com PLEASE NO CALLS BY RECRUITERS!!  <ul class="blurbs"> <li> Location: Portland, Oregon</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Full time salary position at Duke University as an Associate in Research beginning March 1, 2012. Job Summary: The Associate in Research will develop, update and maintain programs and databases to meet programming, data management and reporting needs in support of projects funded by the National Institutes of Health (NIH) and other funding sources. Job Description: Perform complex, integrated computer programming for clinical data applications, including maintenance of existing systems and research/development for future enhancements. Design, code, test, and document SAS and STATA programs for dataset creation, data analysis, data conversion/transfer, graphic production and project reporting. Maintain large, observational databases for ongoing studies. Collaborate with faculty, staff and personnel with outside affilia0ons on study objectives, analysis and planning. Develop tools to support studies as needed Participate in paper preparation based on the statistical analysis performed. Requirements: Individual must have a minimum of a Master's degree and demonstrated quantitative skills including experience programming in STATA and SAS. Interest in health economics desirable. Please contact via email with a cover letter, resume, at least three references. For information on Duke University benefits please go to <a href="http://www.hr.duke.edu//benefits/index.php" rel="nofollow">Duke Human Resources: Benefits</a>  <ul class="blurbs"> <li> Location: Duke University</li> <li> Compensation: Salary position with full Duke University benefits </li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[A RTP-based biotech firm that specializes in vaccine development and production, is expanding its team and actively recruiting for a Lab Technician to assist with contract (3+ month) project needs. You will assist in the areas of Fermentation, Upstream and Downstream Processing. This is an excellent opportunity to break into one of the fastest growing companies in the Triangle. This Process Specialist I will be responsible for biopharmaceutical production as well as documentation and process efficiency improvements -- specifics will depend on area of specialization. Tasks will include: o development of documentation including SOPs and batch records o perform material preparation, equipment set-up and cleaning o inspection and maintenance the production equipment and control systems o collaboration with process support and development groups to assure smooth process transition in manufacturing Client is focusing on candidates who offer an AAS or BS degree or equivalent and experience in a production environment desired. In addition, experience with flexible/disposable single-use systems and technology transfers are a plus. . This is a dynamic and quality-driven setting. Seek candidates with the proven ability to learn quickly, work efficiently and thrive in a high expectations environment. Many more details are available. This role is structured as a 3 month contract with long term potential. Target hourly pay rate is $15. Please forward a detailed resume for immediate consideration. Local candidates only. Thank you!  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: $15/hr</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[We at goBalto (www.gobalto.com) are dedicated to serve the clinical trials community with web-based tools for study startup (SSU). We think of you as the expert, and invite you to participate in shaping future products for clinical trials as well as our current product Tracker, a web-based approach for site initiation. Help us understand what's going on in the clinical trials community. Take us on a tour to understand the ins and outs of your work. Show us what works for you and what doesn't. We are looking to speak with individuals in the Research Triangle Park area between Wednesday February 8th and Friday February 10th, 2012. If selected for this 1.5 hour interview, we will either compensate you $150 for your time, or make a donation in your name to an organization of your choice. Please note: we would like to audiotape the conversation and take pictures for internal research purposes only. Please don't share anything confidential with us. We are interested in your processes, approaches, and generalized examples, at the appropriately abstracted level. We will protect your privacy and leave you with a signed confidentiality form. If need be, we are happy to sign an NDA with your organization. Let your experiences and insights inspire our designs! For consideration, please fill out the below survey: <a href="https://www.surveymonkey.com/s/seeking-clinical-trials-professionals-to-inspire-SSU-tools" rel="nofollow">https://www.surveymonkey.com/s/seeking-clinical-trials-professionals-to-inspire-SSU-tools</a> Thank you, Lucie Richter, director of research at goBalto  <ul class="blurbs"> <li> Location: RTP</li> <li> Compensation: USD 150 for 1.5 hours interview</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Looking for an experience Data Operations Leader for a direct hire position in RTP. The Data Operations Leader has overall accountability for the execution of the Data Operations strategy and the Data Operations' Technology set-up for the project. The Data Operations Leader is providing overall leadership / management for programming, data integration, data processing and statistical services on a project / program. General areas of responsibility include: coordination of the Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders and the client as a single point of contact to ensure that the Data Operations deliverables with regard to timelines, quality, and productivity are being met. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. General: Provide an extensive range of leadership and influencing capabilities to achieve the business objectives and goals for both the company and its clients. Effectively communicate with internal and external customers as well as third party vendors Prioritize effectively and respond to urgent requests within team or from client Participate in cross functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical trials Coordinate technical set-up for complex projects / programs Responsible for the creation and execution of an integrated plan covering all Data Operation deliveries; this includes the coordination of dependencies between Data Operation stakeholders (Data Processing, Programming, Biostatistics) either within the company or at the client Coordinate with the Data Standards Associate and the Technology Integration Architect (if assigned), the enforcement of data standards (as appropriate for a sponsor) and the definition of the data reconciliation procedures, to decrease the need of data mapping for integrated reports such as ISE/ISS or before submission to the sponsor. Project Initiation & Planning Provide input to proposals and attend Bid Defense Meetings as required As needed, participate in a meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client Review (draft) protocol from a Data Operations perspective Attend project kick-off meetings and lead Technical Kick-Off Meeting(s) Identify and request staff necessary for the project team Be trained in client SOPs and disseminate knowledge to the Data Operation project team members, as appropriate Provide input to project tools, project plan, Central File Maintenance Plan, etc. In cooperation with the Project Leader accountable for the deliveries from the technology / data integration team (if applicable) Coordinate the set-up of the Technology platform ' in collaboration with the Data Standards Associate and Technology Integration Architect (if assigned) Ensure all team members have access to tools and documents Ensure information entered into internal management systems is accurate and updated on a regular basis Establish efficient / effective working relationships with other functional Leaders and experts Project Implementation, Control & Evaluation Coordinate Data Operations study activities Provide Leadership and direction to the project team members Provide productivity targets to the project team members Ensure the project is completed within budget, schedule, and according to contract specifications Ensure the project is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill regulations Ensure information entered into management systems is accurate and updated on a regular basis Use Project Plan / Data Management Plan as a management tool to record and measure progress, updating as necessary Coordinate the data quality and data integration approach ' in collaboration with the Data Standards Associate and Technology Integration Architect (if assigned) Oversee support activities for the Technology platform during study execution Early recognize areas of potential problems and provide input into contingency plans Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity Review metrics reports regularly and follow through on actions required Determine the cause of project overruns, recommend and institute corrective action, with input from functional experts, escalate and follow-up as appropriate Implement and instigate process improvements within the project Work with functional experts to track scope of ongoing work to identify CIS in a timely manner Hold team meetings on a regular basis, monitoring the progress of each individual project task, and assessing the overall status of the project. Ensure maintenance of Data Operations project documentation on an ongoing basis throughout the course of a project Oversee maintenance and completeness check of the Central File Provide performance feedback on team members as appropriate Work with third party vendors as appropriate Participate in client, investigator and team meetings Prepare, participate in and follow up on audits / inspections Education: Bachelor's degree and / or other qualification in a science or industry-related discipline Minimum Work Experience Substantial experience in clinical research Demonstrated application of Project Management concepts Proven record of leading a project team in a technical/programming, data processing or statistical environment Individuals should have a strong understanding of the cross functional activities.  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: Up to 100K</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Immediate opening for a chemist position at independent testing laboratory. Must have experience testing vitamins, amino acids, and botanical markers in dietary supplements via HPLC. ICP experience is helpful but not necessary. Email resume with desired starting salary. This is a full time position with medical benefits.  <ul class="blurbs"> <li> Location: Smithfield</li> <li> Compensation: commensurate with experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Kelly Scientific is currently seeking highly qualified biological scientists.  Our clients use cutting edge technology to help advance knowledge pertaining to a variety of fields and industries.  Candidates that meet the requirements below are encouraged to apply.   Requirements: <ul> <li> Bachelor's degree in molecular biology, genetics, biochemistry or a related field</li> <li> Ability to work individually and cohesively as part of a team</li> <li> Effective verbal and written communication skills</li> <li> GLP and/or GMP experience is a plus</li></ul>   Job Duties: <ul> <li> Extraction of DNA and RNA</li> <li> Purification and synthesis of proteins, expression cloning</li> <li> Running gel electrophoresis and SDS-PAGE gels</li> <li> Western blotting and other macromolecules and probing techniques</li> <li> Maintain good record keeping using company and regulated guidelines</li></ul> For immediate consideration please use the following link to apply: <a href="http://kelly.bullhorn.staxapps.net/OnlineApplication/index.cfm?jobID=453677&source=Online%3A%20Craigslist%20%2D%20unpaid" rel="nofollow">Apply Now</a>  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: Hourly</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Senior Programmers SAS with Clinical Exp. RTP NC</h2> <h3>Job Description:</h3> Job Description: *Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation. *Assist in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents. * Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings. * Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department. * Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units. * Create standard macros and applications to improve the efficiency of the department. Experience: First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience. Excellent English written and oral communication skills. Relevant Clinical Trial industry experience Experience working with systems used within the Clinical Trial process (e.g., SAS) <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/2c2e8d96" rel="nofollow">http://ziprecruiter.com/cl/2c2e8d96</a></h3>  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Wellington Group has been engaged to find two (2) Chemists with hands-on experience using analytical chemistry methods for pharmaceutical or biological drug-based products. Put your analytical chemistry skills to work in a new role today! Qualified candidates for this position will have experience with HPLC as well as sound knowledge of basic analytical and bench chemistry techniques. The chemist is responsible for performing analytical and biological tests in support of in an FDA-regulated environment. Responsibilities include: � Perform analytical chemistry assays � Operation of various instrumentation including but not limited to UV/Vis, GC and HPLC � Exercise strong analytical problem-solving skills � Conduct testing methodology used to control raw materials, production intermediates, and final products � Present data from testing and development laboratory activities as required � Perform work in compliance with GLP, cGMPs, safety and regulatory requirements � Conduct testing of samples to provide analytical support of R&D activities � Utilization of chemicals that produce hazardous waste The qualified candidate will have: � BS or MS in Chemistry, or related field � 3+ years pharmaceutical, biological or medical device laboratory experience � Experience with HPLC, GC, Bench Chemistry and GLP / GMP documentation Industry: Pharmaceutical, Biotechnology, Analytical Chemistry, HPLC, GMP, GLP, Medical Device Job Code: 336-32-MH2322 Location: RTP, NC (local candidates only) Recruiter: Lisa Apply directly to: <a href="http://www.maxhire.net/cp/?E55E64361D43515B7D52182B77571D6C482A7E" rel="nofollow">http://www.maxhire.net/cp/?E55E64361D43515B7D52182B77571D6C482A7E</a> Don't wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( <a href="http://www.twgrecruiters.com" rel="nofollow">http://www.twgrecruiters.com</a> ) 910-338-2795  <ul class="blurbs"> <li> Compensation: DOE</li> <li> This is a contract job.</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Phone calls about this job are ok.</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Wellington Group has been engaged to find an experienced Process or R&D Engineer with a minimum of 5 years of hands on experience in scale up from product development to pilot plant and on to commercialization. Excellent opportunity to make an immediate impact with great company. . .put your Engineering and process management skills to work in a new role today! Responsibilities include: - Involved in new product scale-up, process optimization, technology transfer and process validation activities - Develops and implements manufacturing processes for clinical and non-clinical product - Develops a deep understanding of the manufacturing process and how it affects the product performance - Designs, builds, acquires and maintains methods and tools for process improvements - Assists the manufacturing operation in problem solving with regards to equipment and systems - Establishes operating equipment specifications and improves manufacturing techniques - Develops and recommends new processes and technologies to achieve cost effectiveness and improved product quality - Interfaces with various departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology - Creates and edits manufacturing machine related documentation, including Standard Operating Procedure (SOPs) and instrument troubleshooting guides - Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors - Implement process controls to achieve production and quality targets - Perform IQ/OQ/PQ qualifications for equipment and processes - Perform weekly inspections of hazardous waste containers -May transport hazardous waste from satellite accumulation area to chemical waste storage room The qualified candidate will have: - Demonstrated experience with CPK, tech transfer, data analysis and process / manufacturing troubleshooting - 5+ years medical device or pharmaceutical manufacturing, experience in drug combination therapy processes is ideal - BS /MS Mechanical Engineering, Chemical Engineering, or related discipline - Excellent communication skills and problem solving skills - Solid knowledge of current Good Manufacturing Practices (cGMP) applicable to the FDA and comparable international regulatory agencies -Ability to plan and schedule multiple projects and tasks - Good knowledge of MS Office Suite and MS project and basic knowledge of Solid Works Industry: Pharmaceutical, Biotechnology, Medical Device, Process, Engineering, GMP, Validation, Scale-up, Tech Transfer, Solid Works Job Code: 322-41-MH2322 Location: North Carolina Recruiter: Lisa Apply directly at: <a href="http://www.maxhire.net/cp/?E55E6F361D43515B7D52182B77571C68482A7E" rel="nofollow">http://www.maxhire.net/cp/?E55E6F361D43515B7D52182B77571C68482A7E</a> Don't wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( <a href="http://www.twgrecruiters.com" rel="nofollow">http://www.twgrecruiters.com</a> ) 910-338-2795  <ul class="blurbs"> <li> Compensation: Great base, benefits, bonus and many other perks!</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>OK for recruiters to contact this job poster.</li> <li>Phone calls about this job are ok.</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Wellington Group has been engaged to find an experienced Analytical Chemist, at the Manager or Scientist level, with a proven background in the development of analytical methods for pharmaceutical or biological drug-based products. Excellent opportunity to make an immediate impact with great company. . .put your skills in chemistry, pharmaceuticals, scientific analysis and leadership to work in a new role today! Responsibilities include: • Responsible for analysis and validation of all raw materials, in-process materials, final product and stability studies • Development and validation (method development and validation) of analytical methods and assays to support the drug development, product development, product characterization, product pipeline and commercialization of all products produced • Manage the laboratories, staff, hiring, training, mentoring and any oversight of third party analytical lab vendors and services • Develop and writes SOPs • Provide technical support and subject matter expertise, both internal and external • Work with new drug product and/or drug containing products and combined therapies • Responsible for writing scientific reports, papers and technical documents as well as supporting various regulatory filings for new products • Will work with established QA Team to ensure all procedures are completed and documented to internal company standards and that all 3rd party labs and vendors meet quality compliance The qualified candidate will have: • Proven, hands on skills with HPLC, MS, GC, LC/MS, FTIR, UV-VIS • Ability to develop, implement and troubleshoot analytical methods • Experience working with R&D and clinical research material / products • 8 to 10 years of analytical work and scientific analysis, or pharmaceutical or drug-products or drug-containing development work, can include time in post-doc work • Strong verbal, written communication and organizational skills • Capable of managing a laboratory staff, deadlines and a budget • Knowledge of and training in GLP, GMP, and USP guidelines and regulations • PhD in Chemistry, Biochemistry or other area of scientific study is required (please provide details on your post-doc experience) Industry: Pharmaceutical, Biotechnology, Combination Products, Analytical Chemistry, HPLC, PhD, GMP Job Code: 313-41-MH2322 Location: North Carolina Send your resume to Lisa at: 313-41-MH2322@apply.maxhire.net Don't wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( <a href="http://www.twgrecruiters.com" rel="nofollow">http://www.twgrecruiters.com</a> ) 910-338-2795  <ul class="blurbs"> <li> Location: Raleigh area</li> <li> Compensation: Great base, bonus, benefits and other perks!</li> <li> OK to highlight this job opening for persons with disabilities</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Phone calls about this job are ok.</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ THERMALIN DIABETES, LLC CLEVELAND, OH Company Background Thermalin Diabetes, LLC is developing a pipeline of patent pending insulin analogs that address significant unmet needs in the rapidly growing insulin market ($14B today, $54B expected worldwide by 2030). Founded on a portfolio of new insulin analogs invented by Dr. Michel Weiss, Chairman of Biochemistry at Case Western Reserve Medical School, Thermalin's initial focus will be on advancing new rapid-acting and new long-acting insulins into the market. Thermalin's analogs are expected to address many problems associated with diabetes management by providing faster onset, lower cancer risk, reduced weight gain, reduced damage to insulin-producing cells, sustained release, and/or unrefrigerated stability/reduced fibrillation. By addressing multiple, clinically-relevant modalities, Thermalin expects to open new competitive dimensions in the marketplace. Upon clinical validation, these benefits should put Thermalin's new insulins in an excellent, defensible position to win market share. Objectives To develop and perform robust and ultimately GMP methods for the purification of insulin analogs and precursors from microbial and synthetic sources Reports to Director of Research & Development Responsibilities � Develop methods and GLPGMP protocols for purifying novel insulins and their precursors � Scale systems first for animal studies and eventually for clinical-scale production � Train and advise junior staff on purification methodology � Perform assigned laboratory tasks safely, rapidly, and efficiently � Optimize procedures and protocols to improve throughput � Write transferable, GMP-quality protocols � Record results accurately and meticulously Typical activities � Design and implement orthogonal purification techniques to purify proteins efficiently and with high yield � Continuing method improvements to increase yield, efficiency and scale.Perform synthetic protein production methods (e.g., semi-synthesis, chain combination, etc.) � Reporting progress in summary and detail on a daily basis to colleagues and supervisors � Keeping accurate laboratory notebooks; writing detailed, GLP-quality protocols Skills � Excellent "hands" in laboratory protocols involving globular proteins � Expertise with a variety of protein purification techniques: preparative HPLC, gel filtration and ion exchange chromatography, microfiltration, and other related techniques as applied to materials from microbial expression sources (secreted & inclusion bodies) and chemical synthesis, at scales from micrograms to grams. � Deep knowledge of solid and liquid phase protein chemistry and of how proteins behave under a variety of laboratory conditions � Experience with crystallization of bulk proteins desirable � Proven ability to independently troubleshoot HPLC and other purification systems and protocols � Experience with overcoming bottlenecks in scaling protein purification methods � Pharmaceutical formulation of proteins compounds a plus � GMP experience with protein products a plus � Good project planning and time management which lead to timely task completion � Juggling several simultaneous projects � Good listener. Strong, concise, and consistent written and oral communication Personal characteristics � Meticulous and detail oriented, responsible & mature � Passionate, committed to excellence; driven to make projects and company succeed � Persistent/tenacious, proactive self-starter, thorough follow-up; problem solver. � Initiates change. Sense of urgency. � Takes responsibility. Gets things done personally as well as through others � Risk taker; flexible and adaptable. Comfortable with ambiguity. � Good with people; team player; sense of humor � Demonstrated strong ethics Background � Must have 5 years in industry setting post PhD or MS degree � At least 3 distinct, observable examples where achieved meaningful excellence � At least 3 years work focused on protein purification techniques � Must have a Ph.D. or MS in biochemistry or related science  <ul class="blurbs"> <li> Location: Cleveland, Ohio</li> <li> Compensation: 75K-95K depending on experience and background, plus bonus and stock options</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Hello, My name is Robert Suarez and I am currently seeking a Quality Control Analyst II . This position will be in Holly Springs, NC . Details for the positions are as follows; PAY: Negotiable THIS SHIFT IS A SECOND SHIFT: 3PM to 11:30PM Perform biochemistry testing: SDS-PAGE, BCA, enzyme activity assays, immunoassays, DNA Threshold Perform second shift-work Participate in executing method transfer and verification activities Review and approve assay data Assist with assay trouble shooting Ensure thorough analysis of testing failures Develop and maintain SOPs Develop expertise in assigned assays/techniques Perform routine safety check of QC Laboratories Maintain compliance with applicable cGMP requirements Participate in cross-training to support staff availability within QC department Actively involved in day-to-day improvement of procedures/documentation and be a team player to reduce laboratory errors Maintain compliance with legal regulations on occupational safety and health, particularly with regard to hazardous materials. EXPERIENCE: MS/BS degree with 3-6 years of industrial experience in a cGMP manufacturing setting. Advanced knowledge of biochemistry analytical methods and related instrumentation Advanced knowledge of GMPs, safety regulations and data integrity LIMS experience is a plus If you qualify and are interested in hearing more about the position please respond to roberts@thefountaingroup.com. Thanks! <ul class="blurbs"> <li> Location: Holly Springs, NC </li> <li> Compensation: $ negotiable</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Nationwide company is currently in need of an in-house Field Technician for troubleshooting, service and repair of Analytical Instrumentation in a FDA/GMP regulated capacity. Ideal candidate will have 5+ years of experience as an equipment service technician in a pharmaceutical environment. Experience will need to come from performing routine repairs and preventative maintenance of Mass Spectrometers and have knowledge of LCMS/GCMS, HPLC systems. Technician will also be responsible for communicating with scientific staff of service needs and errors. Please respond to posting with resume and/or letter of interest.  <ul class="blurbs"> <li> Location: RTP</li> <li> Compensation: Open for discussion</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Senior Programmers SAS and Clinical RTP NC</h2> <h3>Job Description:</h3> Job Description: *Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation. *Assist in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents. * Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings. * Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department. * Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units. * Create standard macros and applications to improve the efficiency of the department. Experience: First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience. Excellent English written and oral communication skills. Relevant Clinical Trial industry experience Experience working with systems used within the Clinical Trial process (e.g., SAS) <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/2c2e8d96" rel="nofollow">http://ziprecruiter.com/cl/2c2e8d96</a></h3>  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <h1>Miller Ag</h1> <hr> <h2>Sr. Biologist Weed Scientist 2 positions open now!</h2> <h3>Job Description:</h3> Miller Agricultural Recruiting seeks to fill the following role with our client; we seek top candidates for this role. We are currently only considering US based candidates for these roles. Positions are based in the US and depending on role will determine location. To be considered go to: www.millerag.com and in the "candidate" section please download the "Candidate Biosheet" to fill out. Send that and your Resume/Cover to : Darin Miller for review. "Only qualified candidates will be contacted directly" Sr. Biologist, Weed Scientist The successful candidate will be responsible for focusing biological efforts on all aspects of herbicide evaluations for crop and non-crop opportunities. To aid in determining and expanding commercial potential of lead compounds, the individual will utilize existing bioassays, and develop and integrate new assays, to extensively characterize herbicidally-active chemistry against a broad range of weeds within key crop/non-crop segments. The individual will also work with acquisition and project development teams to prioritize compound leads and chemistry testing requirements, and provide input on herbicide opportunity evaluation efforts. The successful candidate will communicate testing results and project status with scientists, project managers and management throughout the Development and Business/Marketing organizations. The individual will report directly to the Herbicide Biology Group Leader. Our client is committed to providing employees with ample opportunities to contribute, lead and be recognized as innovators, to look beyond barriers to provide solutions, to be challenged in what they do and to love doing it. Our client is an S&P 500, US based diversified chemical company serving agricultural, industrial and consumer markets globally for more than a 100 years. As a global leader utilizing advanced technologies and customer-focused research and development, providing innovative and cost-effective solutions to food, agriculture, pharmaceutical, specialty and related industries. Responsibilities: • Work safely within a team environment in support of herbicide product concept evaluations and development. • Champion the evaluation of herbicide products and technologies towards the development, optimization and expansion of crop and specialty use concepts and products. • Test herbicide products and concepts in a range of bioassays to characterize activity, residuality, efficacy, and commercial utility. • Work independently and within a small team, requiring a minimum of supervision. • Create appropriate plans to test experimental hypotheses by identification, planning and organization of resources, including plants, greenhouse space and time requirements. • Research, develop, validate and implement new bioassays as required to meet strategic initiatives and tactical testing needs. • Constantly review, develop and implement plans and schedules to meet an ever-increasing and flexible testing demand. • Effective use of various testing equipment, such as track sprayers and field application implements, to analyze overall performance of experimental herbicide formulations. • Review data to ensure quality and consistent results are being produced by established bioassays, perform statistical analysis, and interpret assay results. • Prepare and maintain stocks of experimental and commercial herbicides. • Collect and summarize data, and deliver results and recommendations as oral and/or written reports as required to R&D scientists and project teams, management, and APG Business/Marketing groups. • Liaise with Development, Regulatory, Marketing, area Business and Development personnel as needed on all aspects of herbicide technical support, protocol generation, milestone timelines, and data requirements. • Transfer information of herbicide development findings throughout the organization. • Maintain complete understanding of all bioassays available for testing including timing, material requirements, assay evaluation, statistical analysis, etc. • Develop technical leadership by publishing and presenting appropriate information at scientific meetings, and/or trade organizations. Required Education: PhD in Weed Science, Agronomy, or related applied life science with at least 3 years’ experience, or M.S. in Weed Science, Agronomy, or related applied life science and at least 6 years’ experience in an applied herbicide or related applied pesticide academic or industrial R&D program. Qualifications: • Strong working knowledge of commercial herbicides and a strategic understanding of agricultural chemical markets. • Understanding of economic, competitive, and practical use factors affecting opportunities in herbicide markets. Working knowledge of current and development herbicide products. • Extensive experience in conducting laboratory, greenhouse and field herbicide bioassays against a range of weed species across various crop and non-crop segments. • Demonstrated experience in developing and integrating new bioassays to understand activity of herbicide leads and various product concepts. • Previous work with, and knowledge of, weed identification and growth stages, weed and crop production techniques, and methods in herbicide screening and advanced testing. • An understanding of field translation issues and objectives, and experience in lab to field herbicide translation assays. • Experience in optimizing testing workflow for efficient and effective throughput and quality data output. • Working knowledge of database systems for recording and displaying bioassay data. • Experience in project-based R&D. • Previous experience in supervising others in a laboratory environment. • Strong customer focus. • Understanding of statistics and the ability to utilize statistical analysis on biological data. • Effective oral and written communication skills. <h3>About Miller Ag:</h3> Miller Ag is a leading Search Firm in the US. Our client's pay all fees, relocation costs if needed and offer an excellent Corporate benefits package. If interested in any of these or other positions with Miller Ag please send us your resume in confidence! See www.millerag.com If these don't fit your needs please tell friend! Also request us on www.linkedin.com for future reference! Send resumes in confidence to: Darin Miller Darin@millerag.com <h3>Apply Now: <a href="http://ziprecruiter.com/cl/7ad6030f" rel="nofollow">http://ziprecruiter.com/cl/7ad6030f</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Neuromonitoring at Cadwell Cadwell is the leading provider of intraoperative neuromonitoring (IOM) equipment in the United States and has a strong presence in the global market. Our IOM line of equipment is used to assess the viability of neural pathways during surgery and provides important feedback to the surgeon regarding how their interventions are impacting neural function and integrity. The success of Cadwell's IOM systems hinges on our robust product platform that provides high performance signal generation and processing capability, our software solutions that help the monitorist and surgeon succeed, combined with our in house support experts. Join our team and interact with our industry leaders, discover and implement solutions to today and tomorrow's IOM needs. Position Summary: The product manager is responsible for developing Cadwell's IOM line of equipment and plays a pivotal role in our future developments in this exciting field. The primary responsibility of a product manager is to ensure that our IOM products excel in the market place by providing our customers with optimal solutions to meet their needs. Day-to-day responsibilities include: � Researching customer requirements � Coordinating product enhancements and modifications � Providing the long term roadmap for IOM products and market growth � Overseeing the development of new products � Validating software and hardware developments prior to release � Staying abreast of the emerging technologies, as well as research and developments in the field � Representing Cadwell at tradeshows and other presentations � Training the global sales force on products � Ensuring that product literature is accurate, up-to-date, and clear � Maintaining a high level of customer satisfaction with existing products Education: � Requires a bachelor's degree in Biomedical Engineering, Neurophysiology, or related discipline; MS or Doctorate preferred Experience: � Minimum of three years of experience in a Product Manager position Skills/Job Knowledge/Ability: � Excellent written and verbal communication skills � Solid fundamental understanding of signal propagation in neural pathways and the effects of stimulating these pathways electrically � Ability to understand and communicate highly technical information for strategic planning and product roadmap development to both technical and non-technical audiences � Ability to accurately assess customer needs and market conditions and partner with software and hardware teams to translate the business requirements into live products � Demonstrated ability to lead people and get results through others � Capacity to keep abreast of state-of the-art product offerings and new technology trends and familiarity with standard concepts, practices, and procedures with the medical field, and create detailed business cases to support those ideas with market and financial analysis � Ability to work successfully as part of a team and can positively adapt to changing requirements, deadlines, and priorities � Knowledge of professional marketing ethics and customer satisfaction issues � Excellent computing knowledge and general technology proficiency � Ability to organize and manage multiple priorities efficiently, exercising independent judgment and discretion Come play a leading role in the growth of Cadwell Laboratories, Inc., a world-renowned medical equipment leader. Join Cadwell and be a part of the team that makes ideas come to life!  <ul class="blurbs"> <li> Location: Kennewick, WA</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Senior Programmers Unix, SAS, Clinical RTP NC</h2> <h3>Job Description:</h3> Job Description: *Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation. *Assist in the production and QC of analysis plans, TLF mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents. * Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings. * Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department. * Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units. * Create standard macros and applications to improve the efficiency of the department. Experience: First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience. Excellent English written and oral communication skills. Relevant Clinical Trial industry experience Experience working with systems used within the Clinical Trial process (e.g., SAS) <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/2c2e8d96" rel="nofollow">http://ziprecruiter.com/cl/2c2e8d96</a></h3>  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>Clinical Team Manager NE/SE</h2> <h3>Job Description:</h3> The Manager is responsible for the oversight of a team or group. This includes ensuring successful performance and delivery of his/her direct report's project deliverables, on time with high quality. The Manager is responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within CLeint company. The Manager may also be part of a project team and be responsible for successful delivery of his/her own project deliverables, on time with high quality. The Manager is responsible to promote new business by participating in project bids and client presentations as appropriate. The Manager is responsible to provide clinical consultation to project teams as needed. The Manager works independently, under supervision of the Sr. Manager, Assc Director or Director. Key Accountabilities Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control of project deliverables and timely delivery of project deliverables. Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team. Maintain an agreed level of productivity/billability and staff turnover. Participate in and contribute to Project bids, including client presentations. Meet client and business needs to have all projects optimally resourced with suitably experienced staff. Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan. Meet percentage of travel and billability guidelines for staff as appropriate. Produce accurate resourcing plans in conjunction with the appropriate Project Team Members. Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget. Ensure that ongoing/revised project documentation and correspondence is accurate and complete. Support team members to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures Provide technical support to team members to ensure that they have the required knowledge to fulfill their duties. Check quality of team deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action. May be responsible for own assignments as project team member. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables. May be responsible to coordinate client or account activities for department or function. May serve as GMBA for a location or country. May manage employees from multiple disciplines (e.g., in smaller countries) and act as role model for location. Demonstrate leadership within department, function or location. This includes taking an active role in departmental, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate. Prepare and submit weekly study specific status reports to Project Team, Sponsors and management and attend project team meetings. Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports. Train and mentor junior staff Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales. Participate in PXL and department system/standards improvement activities. Support efforts for generating business leads (client networking, public speaking, etc.). Departmental or Project tasks as assigned. Travel as needed  Experience: Skills Demonstrated ability to successfully manage a full workload across multiple-projects. Ability to manage and motivate direct reports Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions) Client focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to work in a matrix environment and to value the importance of teamwork. Must be near and airport and able to travel.  Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook. Excellent negotiation skills Excellent analytical and problem-solving skills Ability to lead a virtual global team as required       <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/4e1c6493" rel="nofollow">http://ziprecruiter.com/cl/4e1c6493</a></h3>  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[If you are currently in the job market and are not currently working for an employer, this is a temporary / contract position that is in RTP, NC. 5.5 months + Associate I Responsibilities: The Associate I will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology. The position requires but is not limited to the following: Understanding of basic biological science principles; ability to communicate with peers and management; effective organizational skills; ability to multi-task and coordinate multiple activities in parallel; developing or demonstrated instrument/method troubleshooting and problem solving skills Basic Qualifications � B.S. degree (biological science preferred; 0-2 years of relevant experience)  <ul class="blurbs"> <li> Location: RTP, NC </li> <li> Compensation: ASK</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Currently looking for a number of Regional CRA's for several very well established clients. Must have at least 2 years of monitoring experience and be able to travel 80% if the time. Please see below for more details. Position offers � Competitive compensation plan � Comprehensive benefits including medical/dental, 401K with excellent matching, generous PTO, LTD, STD, flexible spending accounts and work/life balance � Excellent working environment � Second to none training program � Tremendous growth opportunity � Home based office Selected candidates will be responsible for performing all site development, site set-up, site monitoring, and site close-out activities for specific clinical trial investigator sites in accordance with customer expectations and in adherence to FDA, ICH, and organizational SOP requirements. Position Requirements: � BS degree in Nursing, Biology or related discipline � Minimum of two years CRA/Monitoring experience within a pharmaceutical company or CRO � Excellent communication and interpersonal skills � EDC experience preferred Please responde with a resume and a contact number to be considered today. Thank you very much! <ul class="blurbs"> <li> Location: Nationally </li> <li> Compensation: competitive!!!</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Our client, a global specialty pharmaceutical firm with an established and growing presence in the Raleigh area, is actively recruiting for a highly knowledgeable and skilled Medical Writer to join its R&D team in a Principal level role. Company has multiple products on the market and many more in the pipeline. The Principal Medical Writing position is a newly-created role that was necessitated by the many R & D initiatives underway. This Medical Writer will focus on clinical documents and the clinical portions of regulatory submissions. Seek a skilled and experienced medical writer who can bring significant expertise and insight. Further, seek a skilled facilitator who can work closely with the clinical/development teams, lead document roundtables and ensure that all relevant information is accurately and thoroughly shared, evaluated and presented. The writing requirements will be diverse and will involve the research, authoring, editing, formatting and quality review of documents basic to drug development to include: Phase I - III protocols and clinical study reports (CSRs) Summary documents including: Integrated Summary of Safety [ISS] Integrated Summary of Efficacy [ISE] Clinical Overview Clinical Summary Risk Management plans Clinical Study Summaries Clinical parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, IND, and EU Annual Safety Updates This Principal Medical Writer will assume a leadership role on the team by serving as a Subject Matter Expert (SME) as well as contributing to the development of Best-in-Class processes for the writing/submissions organization. Ideal candidate will offer a related degree (advanced degree preferred) and 6+ years producing similar, high-quality documents in a pharma/biotech setting. Bkgd working directly for a sponsor company will be important. Extensive knowledge of clinical document formats/techniques, expert attention to detail and reliable conformance to industry/company standards are presumed and essential. In addition, seek a Medical Writer with demonstrated ability to build collaborative and effective relationships with colleagues and partners. This is a point-person role. Seek natural leader who can thrive. Company will pay excellent wage and relocation for an excellent person. Please forward Word resume for prompt reply.  <ul class="blurbs"> <li> Location: Raleigh, NC Pharma</li> <li> Compensation: $Open$</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[PharmEng has an immediate opening for a Process Engineer Essential Job Requirements: EDUCATION Bachelor's degree in science, chemistry, or engineering related field. Masters degree preferred EXPERIENCE Minimum of 5-10 years of relevant experience Experience in cell culture and vaccine manufacturing environment Experience with production of cell culture and bioreactor Experience with fermentation of cell culture process OTHER REQUIREMENTS Willing /ability to Travel Canadian or USA citizen Valid Driving license and Passport QUALIFIED CANDIDATES SUBMIT RESUME TO ------------------------------------------------------------------------------------- humanresources@pharmeng.com Only those candidates selected will be contacted for an interview. Thank you.  <ul class="blurbs"> <li> Compensation: TBD</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[BIO BASIC INC. has been a leading manufacturer and provider for life science products and related services since 1995. OUR MISSION: A One-Stop-Store Providing the Highest Quality Products At the Most Competitive Price. Conditions Job Title: Territory Sales Manager Place of work: Raleigh, NC Duration: 3 month contract, renewable Type: Full Time Job Description � Successful candidate will advance after consistently exceeding assigned sales targets. � Reports to the Director of Sales and Marketing � Identify and maximize profitable sales opportunities within the existing customer base �Look for new business opportunities within the territory �Present and articulate product features and benefits to customers �Develop territory-specific marketing strategies �Develop a customer contact plan in order to determine call order and frequency �Build strong customer relationships Qualifications � University degree (Biochemistry, molecular biology, microbiology and immunology preferable). M.Sc. preferable. �Exceptional interpersonal and communication skills; technical and analytical skills; problem-solving and organizational skills; presentation skills; highly confident with proven leadership abilities �Excellent understanding of the sales process �In-depth knowledge of the biochemicals, molecular biology kits, PCR-related products, protein markers, culture media and labware technologies on the market �Willing to travel �Transcript and references will be requested.  <ul class="blurbs"> <li> Location: Raleigh, NC</li> <li> Compensation: $40000-$100000</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[POSITION DESCRIPTION: Regional Expression Specialists assist Account Managers in supporting the sales process by proactively providing peer to peer expertise. Driving the technical part of the sales process, the RES will actively contribute to the successful closing of business. The RES will work closely with district management to ensure attainment expression revenue goal. Accountabilities and KPI's - To participate in the execution of account manager and specialist sales process to meet sales quotas. - To expeditiously help customers achieve confidence that Affymetrix Expression technologies can meet their needs - Will serve as a voice of customer back into sales management, marketing and the Expression Business Unit - To achieve pre-defined levels of sales satisfaction Primary Duties and Responsibilities: � Present entire portfolio of Affymetrix Expression solutions -- tailored to customers specific applications � The RES will identify and communicate expression solutions for customers utilizing the wide range of Affy expression tools � The RES must be a resource for technical knowledge and expertise relating to expression studies and NGS workflow � The RES will be the field resource for NGS overall technical knowledge including workflow, data output and validation as it pertains to the potential positioning of microarrays into the NGS workflow � The RES will be a focal point for field based information that will be delivered to the Business Units, sales management and marketing � The RES will be critical to the development of strategy to grow the expression business in coordination with the Expression Business Unit. � The RES will work closely with Affy AM's to close expression business � Assist the sales team with pre- and post-sales activities at seminars and workshops � Participate in the design and delivery of formal training courses and in product pre-launch activities � Maintain records of customer communications and technical support functions through available CRM tools � Comply to the companies regulatory and quality processes � Participate in process and operation improvement opportunities � Comply with company quality management systems, policies and procedures � Additional duties/responsibilities according to business needs POSITION REQUIREMENTS: Education: Bachelor's Yrs of related experience: 3+ years Competencie: - Extensive lab experience with molecular biology techniques in research and/or development - Hands on knowledge of NGS, microarrays and qPCR including bioinformatics. - Solid understanding of expression analysis in clinical, pharmaceutical, and academic markets - Strong interpersonal and team working skills - Strong sales and presentation skills - Knowledge of the competitive landscape - Excellent customer relationship skills Preferred: - PhD or Post Doc Level experience with molecular biology techniques in research and or development ABOUT AFFYMETRIX Affymetrix (AFFX) is a pioneer in creating breakthrough tools that are driving the genomic revolution. The vision, innovation, and devotion of Affymetrix employees help us empower scientists around the world to alleviate human suffering. It is not just the sheer power of our technology that inspires us; it is the potential for it to help people. The culture at Affymetrix is based on core values of daring, passionate and platinum. Our employees create a highly energized, team-oriented work environment. We are an employer committed to supporting the aspirations and achievements of our employees and offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values of daring, passionate and platinum. ***Affymetrix is an affirmative action/equal opportunity employer. We do not discriminate based on race, gender, veteran status, disability or other protected status. Our commitment to a diverse workforce is demonstrated through all aspects of our hiring and employment practices. *** PLEASE CLICK ON THE LINK BELOW AND APPLY ONLINE: <a href="https://careers.peopleclick.com/careerscp/client_affymetrix/external/en-us/gateway.do?functionName=viewFromLink&jobPostId=5580&localeCode=en-us" rel="nofollow">https://careers.peopleclick.com/careerscp/client_affymetrix/external/en-us/gateway.do?functionName=viewFromLink&jobPostId=5580&localeCode=en-us</a>  <ul class="blurbs"> <li> Location: Raleigh, NC / PA & MD Area</li> <li> Compensation: tbd</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[A large pharmaceutical company located in Sanford is in search for a Purification Scientist.. Job Description: Responsibilities include, utilizing a high level of technical expertise, the incumbent is responsible for moderately complex projects related to the development or implementation of processes, equipment, control schemes, and standards. The incumbent would be responsible for preparing and/or executing protocols and writing reports for studies that may be conducted in either the lab or in a production facility. The incumbent is expected to prepare technical reports and make oral presentations to scientists and management, as required. Qualifications: * Excellent oral and written communication skills * Self-motivated, and capable of working independently/collaborative environment * Experience with purification of protein, polysaccharide and/or bioconjugate drug substances * Experience with operation of Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF) * Experience with chromatography systems/processes at lab-scale and production-scale * Experience with Unicorn-based systems (highly desired) >>If interested and seeking more information - please send a copy of your resume ASAP!!<< <ul class="blurbs"> <li> Location: Sanford, NC</li> <li> Compensation: $27.00 per hour</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Validation Engineer/Consultant PharmEng Technology has immediate openings for candidates with minimum of 3-5 years of experience in the following areas: Working knowledge of Laboratory, sterile manufacturing experience, processes and equipments Writing and executing protocols for the following: Depyrogenation process validation /Oven validation Sterilization process/autoclave validation Vial Stopper validation Vial Washer validation Aseptic Validation Filling equipment validation Sample preparation Locations of Projects: in various locations in USA. Education: University Degree in science or related discipline Must be able to speak, read and write English Must be able to travel Must be Canadian or USA citizen  <ul class="blurbs"> <li> Compensation: TBD</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Job Description The Recruiter is responsible for delivering recruiting success to support our pharmaceutical and biotech clients. This will be achieved by utilizing an internal database and additional resources, as well as using traditional and new, creative recruiting ideas to identify qualified candidates. The recruiter ensures that we are providing the best possible talent to our clients. Duties will include, but are not limited to: Utilizing internal database and additional resources to identify potential candidates Establishing new, creative recruitment methods to attract qualified professionals interested in contract, contract to hire and direct placement employment Developing a pipeline of candidates for contract roles Sourcing, screening, interviewing, presenting and hiring qualified candidates Maintaining on-going relationships with candidates with the objective of identifying roles that fit their background and interests Identifying networking activities Candidate Qualifications The recruiter will be responsible for attracting qualified professional to present to our clients in the pharmaceutical and biotech industry. The ideal candidate will have 2-3 years of recruiting experience. The candidate should have a proven record of effective recruiting, sales and/or customer service skills. The person must be able to think creatively and work in a team environment. The candidate must be willing to take initiative and present as professional, enthusiastic, and personable. Strong written and oral communication skills and problem-solving skills are required. Education Qualifications Bachelor's degree preferred OR minimum of 5 yrs experience managing full life cycle recruiting. Please respond to this ad with a cover letter and resume. <ul class="blurbs"> <li> Location: Cary</li> <li> Compensation: TBD</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Perform a variety of complex technical duties involved in conducting research laboratory tests, experiments and determinations to obtain data under Good Clinical Laboratory Practices (GCLP); compile, analyze, document and draw tentative conclusions from experimental results. Confer with lab manager/principal investigator to review work assignments and develop plans for experiments; make minor modifications to existing laboratory procedures and techniques to meet the needs of the particular equipment as required. Attend all required training and comply with all safety and operations procedures and assist the lab manager/ principal investigator with lab audits and reports. Prepare and process specimens for complex immunological procedures, including but not limited to: PBMC Processing, Flow Cytometry, Cell Culture, Luminex array assays, quantitative PCR array assays and devise experimental techniques for testing and analysis as directed by laboratory manager. Maintain quality checks on safety of laboratories, including biohazards, and ensure maintenance of the facilities according to Good Clinical Laboratory Practices. Work with and maintain liquid nitrogen freezers and tanks on a regular basis. Collect information and data through observation, experimentation, and various other methods, to include operating highly technical laboratory instruments and equipment. May assist with shipping and transporting biohazardous samples to other labs around the world, including liquid nitrogen shipping and dry ice shipping, following federal shipping guidelines. Ensure all samples are stored, cataloged and entered into our inventory and sample databases. Education, Skills, & Experience Requirements � Bachelor's degree in biological science or related field � Basic skills in laboratory techniques � Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills � Must be detail-oriented, well organized with strong communication skills and ability to work in an interactive team environment. Apply to: Duke Human Vaccine Institute Email: dhvi.careers@notes.duke.edu Please reference "RTIIS" in the subject line of email Duke University Medical Center is located in the energetic and progressive Research Triangle area of North Carolina. Duke University is an Equal Opportunity/Affirmative Action Employer.  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: commensurate with experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Attention UNC and Duke Graduate Students and Post Docs! AMERICAN JOURNAL EXPERTS, LLC (AJE) is a network of American PhD students and post docs dedicated to helping international researchers publish their findings in the best English language journals possible. AJE is hiring UNC and Duke MA, MS, PhD students and post docs to take manuscripts originally written by non-native speakers and polish the English for spelling, grammar, and flow so that language is not a barrier to the communication of ideas. Editors work remotely from anywhere with a stable internet connection and can pick their subject areas, set their own availability, and decide how much work they want to request at any given time; these settings can be adjusted at any time. Compensation is based on manuscript length and the assignment's customer's chosen turnaround time. Editors must be native speakers of English and either hold a graduate degree or be in the process of earning one. Most submissions are in technical fields, and we need contractors in the sciences, engineering, medicine, dentistry, and agriculture at this time. For more information and to apply online, please visit: <a href="https://careers.journalexperts.com/" rel="nofollow">https://careers.journalexperts.com/</a>  <ul class="blurbs"> <li> Location: NC (remote)</li> <li> Compensation: 25$/hr</li> <li> Telecommuting is ok.</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Are you an outgoing individual who has excellent communication skills?! PATIENT RECRUITMENT SPECIALIST needed at busy medical/clinical trial office to manage all aspects of patient recruitment for ongoing clinical trials. Requirements: � Must know medical terminology � Possess excellent communication skills � Computer knowledge � Great telephone manners � Be a team player Be able to multi-task and handle several job responsibilities Previous patient recruitment or medical office experience is a plus. Please send your resume along with salary requirements via email.  <ul class="blurbs"> <li> Location: Raleigh, NC</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Upstate Environmental firm is seeking environmental field personnel. Experience in Asbestos, Lead and Mold remediation required min 2 yrs experience Current certifications desired but not required. Additional experience in duct cleaning, mechanical, plumbing, electrical and building trades a plus.  <ul class="blurbs"> <li> Location: Western NC</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[For more than 40 years, Berkshire has been a global leader in the engineering and manufacturing of cleanroom and controlled environments products. With manufacturing sites in the USA, UK and China, and sales operations on four continents, Berkshire has the capabilities to mee the smallest and largest demands no matter where our customers are located. Berkshire Corporation has an immediate need for a highly motivated well-organized individual with a desire to meet the quality expectations of our global customers and provide quality oversight of operations in North Carolina. Duties include developing processes, protocols and checks and balances to meet continuous in process and finished goods specifications and will work with raw materials, packaging, WIP and finished goods. Duties will be performed in accordance with Berkshire policies and procedures. Education/Experience: Bachelor's degree in a business or science related field. Quality management experience in a manufacturing environment for a minimum of 5 years. Solid understanding of sterility validation and guidelines/processes, IQOQPQ and ISO compliance. FDA, cGMP, ANSI, AAMI familiarity. Required skills include excellent documentation, devising procedures, developing coworkers, insuring compliance and follow through. Attention to detail crucial with ability to handle several tasks while maintaining a positive attitude. Must be self-motivated and excellent at problem solving. MUST have excellent computer aptitude and knowledge of ERP systems. Submit resume for consideration. <ul class="blurbs"> <li> Location: Whitsett, NC</li> <li> Compensation: tbd</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Operate one or two reactors for determining the performance of catalysts, including preparation of catalyst samples, loading of reactor, operation of reactor, collection and analysis of gas samples from the reactor, summarization of data, unloading of reactor, and handling of compressed gas cylinders. The data collection and reporting must be accurate and neat. Critical deadlines must be met. The position supports Production, Development, and Sales and Marketing. The technician must work collaboratively with others in the laboratory, but much of the work is independent and self-directed. Primary Responsibilities � Satisfy all certification requirements for operation of the reactors and all testing and monitoring equipment � Demonstrate ability to work independently. � Know and follow all safety rules. � Know and follow all procedures for the preparation of catalyst samples, loading of the reactors, setting and verifying of reactor operating conditions, collection of samples and data from the reactor, analysis of gas samples, recording of analytical data, and unloading of reactor. � Set up experiments based on conditions provided on Laboratory Request Forms (LRF's) and identify unusual conditions or settings which require attention from Lead Technicians and the Laboratory staff � Use knowledge and experience to solve many of the minor problems and issues that arise during operation of the reactor. � Operate reactor and associated equipment, such as gas analyzers, FTIR, and chromatographs, properly and safely � Perform wet chemistry operations (such as workups for determination of NH3, SO2, and SO3) with good technique � Perform some routine maintenance procedures and generally maintain reactors and equipment in an orderly and careful manner � Know and perform reactor and instrument checks, audits or calibrations as required � Promptly report unusual issues and problems that arise while performing job functions � Use the reactors as efficiently as possible by carefully planning work and job tasks for a shift at the start of the shift. � Assist in performance of special work on the reactor � Make improvement suggestions Qualifications � 4-yr degree in biology or biochem or in a technical field, such as Chemistry, Engineering Technology, Environmental Technology, or several years of related technical experience. (A higher degree, such as a bachelor's degree in a technical field, is also appropriate. Many armed forces experiences also provide excellent foundation for this work.) � Ability to operate and care for laboratory analytical instruments, including FTIR spectrophotometers, chemiluminescence analyzers, and chromatographs � Ability to understand use and function of complex spreadsheets and to input data to them in an accurate and appropriate way � Mechanical skills sufficient to solve minor problems with equipment such as test instruments, sample trains, pumps, meters, electrical problems, and computer operations � Ability to communicate effectively with others regarding work issues and problems � Willingness to work any shift other than normally-assigned shift for periods of a few days to several weeks to allow the laboratory to meet customer needs � Initiative to plan and execute work efficiently and perform it accurately  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: $16-$17/hr</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[CLINICAL TRIALS SITE MANAGER/DIRECTOR neeeded for a TMO(trial management co)/multicenter investigational site. Job description: The Site Director/Site Operations Manager is responsible for management (and communication to senior management) of multiple clinical projects conducted within the Medical Research Facility(early stage phase 1 unit, late stage ph 2-4 facility). This included, but not limited to all research staff management, planning and execution of clinical trials, communucations with Sponsors and CROs; internal communications with Contract and Finance departments and BD/Marketing. Role Responsibilities: o Lead the Trials Management Team o Responsible for the consistent planning, implementation and successful completion of clinical research activities for clinical trials conducted at multiply sites. o Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures. o Follow and implement Trials conduct in conjunction with the Medical Director and key team members. o Conduct study operational feasibility assessments and risk assessments o Ensure timely enrollment in all trials conducted at facility. o Communicate with Sponsorsregarding study progress issues,, and communicate study progress/status on a regular basis to the Medical Director, PI and company President. o Assure proper study documentation is maintained and archived. 0 Assists Senior Management in identifying new business opportunities in the sector, including, but not limited to, the addition of new sites/locations within the region. 0 Hire, train and manage all research personnel. Skills sets required: . Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organizational skills, communication and quality orientation . Proven interpersonal, communication (written and verbal) and organizational skills . Proven ability as an effective leader is required (e.g. training, decision making, problem solving, negotiating etc.) . Commitment to teamwork . Ability to utilize various electronic systems and software- intermediate computer skills required . Ability to travel(very limited travel) Language: . English Education and experience required: B.S. in scientific discipline/life sciences (Pharmacology, Toxicology, Biology, Biochemistry, Physiology or closely related discipline). Must have at least five (5) years of management experience in the clinical research arena. Direct site management experience is preferred. Must have previuous experience as Lead CRC, Site Manager, or Project Manager at Sponsor/CRO. <ul class="blurbs"> <li> Location: Raleigh,NC</li> <li> Compensation: Based on experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Contract to Hire My name is Hal and I represent The Fountain Group. We are a national staffing firm and are currently seeking an Greenhouse Technician for a prominent client of ours. This position is located in Durham, NC. Details for the positions are as follows: Job Description: Perform generalized greenhouse work such as planting, propagation, watering, fertilizing, harvesting, tissue sampling, data collection and greenhouse upkeeping. Job Requirements: Knowledge of plant growth and development Able to lift and/or move heavy object (50 lb) Able to work in greenhouse environment (periods of over 90F and dusty) Able to work 40 hours per week and on some weekends If you are interested in hearing more about the position please respond to this email with your resume attached or contact me at (813) 321-6344. *Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.  <ul class="blurbs"> <li> Location: Durham</li> <li> Compensation: $14.00</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Environmental Consultant/Trainer; Safety Consultant/Trainer Environmental Resource Center has positions open for environmental and safety consultants at our office in Cary, NC. You must have excellent writing and speaking skills. We currently have an opening for a top-notch consultant/trainer with expertise in: � RCRA hazardous waste regulations � DOT/IATA/IMO hazardous material transportation regulations � Environmental audits � SARA Title III � CWA regulations � CAA regulations � OSHA general industry standards � OSHA audits � Online computer-based training instructional design and implementation You must have at least 2 years of experience in government or industry environmental and/or compliance and be able to immediately train the subject matter to both novices and experts. Strong consideration will be given to applicants who have experience presenting training on more than three of the topics listed above. In addition to instructing seminars and on-site training programs, the position also includes maintenance of training materials (books, PowerPoints, computer based training), working on consulting projects, business development, development of future classes, and keeping our customers satisfied. Environmental Resource Center, Inc. is a full-service environmental and safety consulting firm that has been serving the needs of the public and private sector since 1981. Our primary areas of expertise are environmental and safety training and consulting. We provide public seminars from coast-to-coast that deal with hazardous waste regulations, hazardous material handling, stormwater regulations, SARA Title III and OSHA regulatory compliance. In addition to our public seminars, we provide customized live and online training programs. We also support our clients with environmental, transportation, and safety consulting services. If you meet our qualifications, are enthusiastic about regulations, have the ability to entertain attendees, and would love working for an energetic, ESH consulting firm in Cary, North Carolina, please submit your resume, salary requirements, and references to aknight@ercweb.com. Applications not including these three items will not be considered. Environmental Resource Center offers a competitive salary based on experience, a 401(k) retirement plan, medical and dental coverage, and other great benefits. Visit <a href="http://www.ercweb.com" rel="nofollow">http://www.ercweb.com</a> to find out more about Environmental Resource Center.  <ul class="blurbs"> <li> Location: Cary, NC</li> <li> Compensation: Competitive salary based on experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Our client located in Durham, NC has an immediate opening for a Research Associate/Scientist, Analytical and Formulation Development. This is a contract opportunity for approximately 6 months. Responsibilities include: �Apply biophysical, biochemical and biopharmaceutical principles and techniques to develop protein formulations (liquid or lyophilized). Strong fundamental understanding of protein chemistry is therefore essential. �Conduct and monitor stability studies of proteins, monoclonal antibodies, and peptide. �Experience with LC-MS/MSMS analysis of peptides and proteins. Hands-on experience with bio-analytical techniques such as HPLC, SDS-CGE, IEF, Fluorescence and other techniques applicable to monitor physical and chemical stability of the proteins. �Perform protein characterization using wide range of techniques and troubleshoot problems independently. �Applicants will interact with internal and external collaborators, and should possess superior written and oral communication skills. A good publication tracking record is therefore important Requirements: �A bachelor of science, master's degree or Ph.D. in biophysical/biochemical sciences, pharmaceutical sciences, biochemical engineering or other scientific discipline or equivalent with a minimum of two years experience relevant to the responsibilities of the position. Local candidates only <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: $25-$27 per hour</li> <li> This is a contract job.</li> <li> This is at a non-profit organization.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[A well recognized leader in the manufacturing sector seeks a seasoned plant floor integration specialist for an internal role as Automation Team Leader. BSEE or similar technical discipline with 8+ years experience in pharma, cGMP, GXP and FDA regulated manufacturing. Reply confidentially to this post with resume and salary history. This position has been approved for hire now. There is one additional automation integration support engineer position approved for 1st quarter 2012.  <ul class="blurbs"> <li> Location: North Carolina</li> <li> Compensation: Commensurate with experience level</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Early stage Raleigh technology company seeks a full-time Process Technician. Your skills and attention to detail in learning our unique process for production of advance polymer materials will help build better products in energy, filtration, medical and other fields. Candidates should have a college degree and preferably experience in a scientific lab setting. Ideal candidate will have experience working with polymers and basic understanding of fluid dynamics and/or chemical process development. Please email resum� to be considered for this position.  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Based on Experience</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ <img src="http://filter.to/100x100/http://s3.amazonaws.com/docs.ziprecruiter.com/uploads/ec8f9e0b.jpg"> <h1>Precept Life Sciences</h1> <hr> <h2>On-Site Monitoring Managers- any Region</h2> <h3>Job Description:</h3> Key Accountabilities Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control of project deliverables and timely delivery of project deliverables. Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team. Maintain an agreed level of productivity/billability and staff turnover. Participate in and contribute to Project bids, including client presentations. Meet client and business needs to have all projects optimally resourced with suitably experienced staff. Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan. Meet percentage of travel and billability guidelines for staff as appropriate. Produce accurate resourcing plans in conjunction with the appropriate Project Team Members. Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget. Ensure that ongoing/revised project documentation and correspondence is accurate and complete. Support team members to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures Provide technical support to team members to ensure that they have the required knowledge to fulfill their duties. Check quality of team deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action. May be responsible for own assignments as project team member. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables. May be responsible to coordinate client or account activities for department or function. May serve as GMBA for a location or country. May manage employees from multiple disciplines (e.g., in smaller countries) and act as role model for location. Demonstrate leadership within department, function or location. This includes taking an active role in departmental, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate. Prepare and submit weekly study specific status reports to Project Team, Sponsors and management and attend project team meetings. Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports. Train and mentor junior staff Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales. Support efforts for generating business leads (client networking, public speaking, etc.). Travel as needed  Skills Demonstrated ability to successfully manage a full workload across multiple-projects. Ability to manage and motivate direct reports Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions) Client focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Ability to work in a matrix environment and to value the importance of teamwork. Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook. Excellent negotiation skills Excellent analytical and problem-solving skills Ability to lead a virtual global team as required.  Must be able to travel and be near an airport. Will Manage a team of 10-12 CRA's. 5 years of line management experience is required along with  bid process experience.         <h3>About Precept Life Sciences:</h3> Precept Life Sciences is a full service recruitment firm specializing in Clinical and Scientific candidates for Pharma, Biotech, CRO's and Medical Device companies nationwide. <h3>Apply Now: <a href="http://ziprecruiter.com/cl/9af21e55" rel="nofollow">http://ziprecruiter.com/cl/9af21e55</a></h3>  <ul class="blurbs"> <li> Location: Raleigh</li> <li> Compensation: Apply for more info</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Please email your resume in word document to the link provided for consideration. Senior Programmer (Epi Programmer) Remote (100% work from home) 5 Openings Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience with large databases and observational research/epidemiology methods is strongly desired. Strong documentation, communication, enthusiasm, and time management skills are essential. Basic Qualifications � Bachelors degree in Computer Science, Statistics, Mathematics, or other subject with high statistical content � 8 years programming experience � Statistical programming using the SAS system Preferred Qualifications � Masters degree in Epidemiology, Biostatistics, Computer Science, or other subject with high statistical content � Epidemiology Programming using SAS � Pharmaceutical industry experience � Project planning and management � Team participation and effectiveness � 10 or more years programming experience � Software development & design  <ul class="blurbs"> <li> Location: Remote</li> <li> Compensation: Pay rate: 54/hr w2 (Health, Vision, Dental and 401k) or 60/hr 1099</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[My name is Allison and I represent The Fountain Group. We are a national staffing firm and are currently seeking a QA Project Manager for a prominent client of ours. This position is located in Holly Springs, NC Details for the positions are as follows: Job Purpose To develop and implement a robust planning and scheduling tool for the Holly Springs Quality Assurance Team. Major Accountabilities � Lead the process of developing integrated strategic and operational plans for Quality initiatives utilizing robust project management methodologies. � Optimize and track progress of project plans (time, resources). � Identify issues and lead contingency planning. � Develop tool to accurately plan and schedule QA tasks, taking into account all site project schedules Requirements � Minimum of 3 years in GMP regulated environment with project management responsibilities. � Excellent communication skills, ability to drive and lead cross-functional teams. � Able to manage 10-15 projects at once. � Bachelors Degree in a technical Discipline such as engineering or life sciences. Please forward an updated resume for consideration. Thank you :)  <ul class="blurbs"> <li> Location: Holly Springs</li> <li> Compensation: $D.O.E.</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Summary: Ideally seeking a candidate with protein chemistry background. Services include Formulation, and Analytical Method Development as well as cGMP analysis for monoclonal antibodies, recombinant proteins and peptides in a variety of dosage form such as liquids and lyophilized powders and suspensions for injection, topical gels, and other novel delivery systems. Responsibilities � Development, validation and transfer of analytical methods for SDS-Page and HPLC � Biophysical characterization techniques on proteins. � Formulations development activities as assigned. � Managing cost and time constraints in meeting committed targets and schedules. � Maintaining a current understanding of FDA regulations. � Conduct data analysis and trending for multiple projects. � Produce high quality documentation suitable for regulatory requirements.  <ul class="blurbs"> <li> Location: Durham, NC</li> <li> Compensation: hourly</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Local Trial Management company has an opening for a Clinical Research Coordinator at our office based practice Raleigh Durham Area. If you are looking for a stable, fast paced and growing Company with more than 25 years in the industry that is committed to innovation, excellence and integrity, then this may be the next step in the advancement of your career. The Clinical Research Coordinator works under the supervision of a Principle Investigator and Site Manager to enroll and conduct pharmaceutical sponsored studies. This will include meeting with monitors and communicating with physicians and research personnel. Local travel will be required (up to 10%). Qualified candidates must have the following experience in order to be considered: � 2 or more years of experience working in multi-therapeutic, dedicated research sites (FDA, GCP's, & ICH) � Certified Clinical Research Coordinator eligibility � Experience conducting pharmaceutical sponsored studies in accordance with FDA regulations and good clinical practice guidelines. � Experience enrolling eligible subjects into research studies � Experience preparing CRF's � Must know active protocols � Experience reviewing and conducting Informed Consent process with subjects � Experience screening patient charts to identify eligible study patients, and communicating with physicians � Experience monitoring treatments to verify that proper drug dosages were given per protocol requirements and that necessary lab work, x-rays, etc. are completed on schedule � Experience with patient recruitment � Experience recognizing and reporting AE's and SAE's to physicians, supervisor, IRB and to Sponsors as required by protocol � Experience reading, responding to, and filing all information regarding assigned protocols, including regulatory documents, IRB and Sponsor correspondence and data clarification requests � Solid organizational and communications skills � Personable, outgoing and able to work independently � Computer savvy with Microsoft Office Suite � Able to multi-task in a fast paced work environment � Able to travel locally up to 10% of the time(valid DL and reliable transportation is a must) If you are ready to join an exciting, progressive company and have a strong work ethic, join our team of experts! We offer a highly competitive salary and a comprehensive benefits package. For immediate consideration, please respond via email with resume and salary requirements.R EQUIREMENTS Education/Experience: Bachelor's Degree from four-year College or University and two or more years of experience in healthcare and research (GCP) training. Must have at least 2 years Study coordination experience.  <ul class="blurbs"> <li> Location: Raleigh, NC</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[ Experienced Clinical Research Coordinator EXPERIENCED CRC NEEDED. Minimum of 2 to 3 years of experience coordinating Clinical Trials at an investigational site. Research facility in Raleigh, NC is currently seeking experienced Clinical Research Coordinator. Successful candidate will demonstrate knowledge of study protocol by adherence to study guidelines. Incumbent will be responsible for supporting and conducting research for assigned study protocols and careful monitoring of research participants and procedures under principal investigator guidance to include: � Screening and interviewing potential study participants. � Planning, scheduling, and executing day-to-day research activities � Maintaining case report forms, charts and documentation. � Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Minimum qualifications include excellent communication and organizational skills; detail-oriented; strong interpersonal skills; and decent computer skills. Ability to perform phlebotomy and other clinical functions a must. MUST have 2 to 3 years of experience coordinating Clinical Trials at an investigational site. Medical/clinical background or a bachelor's degree in a medically related field or nursing licensure, including LPN, desired. Medical assistant certifications will be considered. Please send resume and salary requirements via email.  <ul class="blurbs"> <li> Location: Raleigh, NC </li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Intrexon is the future of synthetic biology in the areas of human therapeutics, animal sciences, protein production, industrial products and agricultural biotechnology. With our rapid growth we are seeking talented individuals to join the team. Intrexon Corporation is seeking a LIMS and Automation Specialist for its AgBio Division based in Research Triangle Park. Job Description: The LIMS and Automation Specialist will be responsible for delivering and continuous maintenance of an appropriate LIMS solution to support evolving needs of high throughput assay platforms (biochemical, metabolites, phenotypes) for transgenic mushroom and plants. DUTIES AND RESPONSIBILITIES: � Map laboratory workflows and work with management to identify the optimal LIMS solution for immediate and future needs of the AgBio Division. � Implement LIMS and work either independently or with external vendors or internal developers in extending LIMS as needed for continuing support of changing workflows. � Develop custom data reports as needed for project management and work with developers to build data access and analytical tools for scientists. � Contribute to the development of complex data analysis batch processes and databases intended for automated data mining and knowledge building. � Train laboratory personnel in use of interactive components of the LIMS. � Install and maintain (bio)informatics and analytical packages in Linux and Windows. � Perform other duties as assigned by supervisor. EDUCATION AND EXPERIENCE: � B.S or M.S. in molecular biology, computational biology, bioinformatics or related field. � Direct experience with high throughput automated bioassays platforms and 3-5 years experience in development and maintenance of LIMS in biotech or pharmaceutical industry � Relational databases and programming skills � Strong background in working and performing administration tasks on Unix and Windows platforms DESIRED KEY COMPETENCIES: � Ability to work creatively and efficiently in a fast-paced, start-up company environment. � Ability to maintain a high degree of accuracy and attention to detail. � Excellent planning, organization, and execution skills. � Ability to write comprehensive reports and prepare PowerPoint presentations. � Ability to communicate effectively with team members and management. � Positive attitude and good interpersonal skills. � Ability to follow instructions properly and to accept constructive suggestions. � High ethical standards and trustworthiness. Interested Parties are encouraged to view our corporate website at: <a href="http://www.dna.com" rel="nofollow">http://www.dna.com</a> And apply directly online at: <a href="http://www.dna.com/Jobs/LIMS-and-Automation-Specialist" rel="nofollow">http://www.dna.com/Jobs/LIMS-and-Automation-Specialist</a> <ul class="blurbs"> <li> Location: Research Triangle Park</li> <li> Compensation: DOE</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[Lab assistant - 6 months. If interested, please respond with Word formatted resume This is an entry level position and we are looking for recent college graduates or 1-2 years of experience. Masters and doctorate degrees cannot be considered. contract position Hours of Work: 8am-5pm Work Environment: Laboratory Shift Requirements: Day Job Description: Residue analysis for plant/soil/animal and water matrices with established methodologies; and e-fate metabolism studies Requirement: Candidates are expected to be able to talk about their experience using the testing equipment and lab techniques. Education: bachelor degree in Chemistry/biochemistry/environmental major Note: No Masters or PhDs degrees submitted. experience desired: New graduate or 1-2 years experience Equipment skills: desire skills: wet chemistry, GC/MS, LC/MS/MS, HPLC; LSC radiochemistry Additional Vendor Instructions: 1. Candidates should have Chemistry/biochemistry/environment major 2. GPA should be written in the resume or in the submittal 3. New graduate or some experience in analytical/organic chemistry  <ul class="blurbs"> <li> Location: RTP, NC</li> <li> Compensation: market</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>

<![CDATA[The Engineering and Validation Division of A.N.D Consulting, Inc are seeking engineers and validation specialists to join our core team of excellence driven professionals to fill the following roles that may become available in the upcoming months and year: PROCESS ENGINEER PROJECT MANAGER EQUIPMENT VALIDATION ENGINEER/SPECIALIST CLEANING VALIDATION ENGINEER/SPECIALIST PROCESS VALIDATION ENGINEER/SPECIALIST TECH TRANSFER/START-UP ENGINEERS. JOB REQUIREMENTS BS in Engineering or Life Sciences (Chemical Engineering preferred). Must be hands on and field experience. Minimum 3 years industry experience in a GMP manufacturing environment. This position is based in Durham, NC but you must be willing to travel locally, nationally or internationally. DESIRED TRAITS You need to demonstrate the following traits to succeed in our company: Provide technical support to the manufacturing process including troubleshooting, debottlenecking and process optimization in a solid dosage GMP Pharmaceutical Environment. Candidates need to have strong writing skills, and a high GMP Compliance aptitude. The ability to effectively build and maintain relationships in order to effectively negotiate. Solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency. Oral and written communication skills. Attention to detail. The ability to exhibit flexible thinking. A continuous improvement and quality mindset. The ability to enable and drive change. The desire and ability to train and mentor young engineers. Ability to drive projects to consensus and approval. COMPANY INFORMATION The Engineering and Validation Division of A.N.D. Consulting, Inc. provides Consultation Services to Pharmaceutical and Biotech companies within the global market. Our services include: Project Management System Design Commissioning/Start-Up Master Plan Development Equipment Qualification Automation and Control System Qualification Cleaning Validation Writing and Execution of Validation Protocols Process Validation Process Studies Quality Assurance Services EXPECTATION We expect our consultants to be professional and get the job done in an effective AND efficient manner with minimal guidance and supervision. We expect our consultants to excel at their work, By working hard, being diligent, asking the right questions, meeting project deadlines, and exceeding client expectations. While being honest, having integrity, taking personal responsibility and having respect for people.  <ul class="blurbs"> <li> Location: Nc.</li> <li> Compensation: nego</li> <li> This is a contract job.</li> <li>Principals only. Recruiters, please don't contact this job poster.</li> <li>Please, no phone calls about this job!</li> <li>Please do not contact job poster about other services, products or commercial interests.</li></ul> ]]>