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<![CDATA[Job Description: File Training Documentation. Assist with the review of training documentation Follow up with trainee to correct documentation errors. Pharma experience preferred This is a contract position]]>

<![CDATA[Kelly Scientific Resources is currently seeking an experienced scientist for a pharmaceutical company in Sanford, NC. This opportunity is in the Process Development group in Vaccine Development with a company that is consistently involved in some of the most innovative research within the pharmaceutical industry. This is a one year contract position. The work schedule is Monday through Friday, working an 8 hour shift between the hours of 8 am and 11 pm. Job duties: - Participate as needed in vaccine development clinical projects - Collaborate with development personnel during batch production - Operate ultrafiltration/diafiltration skids, chromatography column skids, depth filter housings, and transfer lines - Perform aseptic transfers - Perform testing with spectrophotometer, pH meter, and gram stains - Submit samples to QC and Analytical Departments - Utilize the approved LIMS to enter sample information - Adhere to site-specific SOPs and policies Requirements: - BS in science - Two years of previous experience in a GMP environment utilizing controlled documents and GMP documentation practices required - Experience in downstream operations is preferred Please apply online at www.kellyscientific.com or send resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at www.kellyscientific.com. ]]>

<![CDATA[Are you a natural multi-tasker? Do you like a fast-paced work environment? Are you looking to put your documentation and editing savvy to the test? Our client is responsible for the discovery and development of some of today's most innovative products. Kelly Scientific Resources is currently seeking a Document Control Specialist for a long-term contract in Durham, NC. Responsibilities Include: - Database management - Formatting technical reports and documents - Binding documents - Document tracking - Routing documents for approval Successful candidates will be highly proficient in manipulating data in WORD and EXCEL. An Associate�s Degree in a scientific discipline is highly desirable. This project requires a long-term commitment and could potentially lead to full-time employment opportunities for the right candidate. Pay is commensurate with experience, relocation benefits are not offered. Please apply online at www.kellyscientific.com, or email your resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at: www.kellyscientific.com ]]>

<![CDATA[Are you a recent graduate looking for laboratory experience within a clinical/laboratory setting? Kelly Scientific Resources is currently seeking an organized, detail-oriented individual to work within a local biotechnology company. Primary Accountabilities: - Management and transport of human specimens between laboratories - Slide preparation and organization - Sample and specimen processing - Data collection - Laboratory upkeep The ideal individual will be meticulous, able to learn quickly, and have a laboratory background. Experience with specimen processing is a must. This position requires an Associate�s Degree in a life science, with at least one year of laboratory experience. This is a long-term contract position, with first shift hours (M-F, 8AM-5PM). Please apply online at www.kellyscientific.com, or email your resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at www.kellyscientific.com ]]>

<![CDATA[Lab Pack Field Chemist position for an Environmental/Industrial Services Company located in the Burlington, NC, area. One year experience as a Lab Pack Field Chemist required in the Environmental/Industrial Services industry. Salary commensurate with experience up to $35,000 annually.]]>

<![CDATA[Sales Manager- Testing Lab Essential Duties: Implements sales strategies to achieve high performance business results Participates in customer relationship events to build beneficial business partnerships Maintain and build client base through sales calls and other means of communications Plan, budget monitor and report on expenditures in your area of responsibility Attending trade shows within the industry Additional Knowledge and Skills: Experience in aerospace , nuclear, automotive or metal fabrication Knowledge of testing lab practice a plus Experience in managing complex business relationships Developed oral and written communication skills to meet variety of communication needs (performance reviews, presentations, employee training and development) Experience Areas: Must have demonstrated success in sales and marketing Must have demonstrated success in writing business and sales plans Must have knowledge of determining pricing for services Must be proficient in standard office software and computer systems Education and Experience level: Bachelor�s degree Minimum experience level 3+ years Please send resume and salary requirements This position is based out of Charlotte NC Salary plus commission and travel expenses ]]>

<![CDATA[TITLE: Environmental Economist/Analyst JOB DESCRIPTION: Consulting firm that supports air pollution and climate change projects for both public and private clients seeks an environmental economist/analyst. Duties include database development (using MS Access and Excel), technical/economic analysis, research, and report writing as directed by senior staff. Position requires excellent attention to detail. EXPERIENCE: Entry- to mid-level (0 to 3 years of experience). EDUCATION: Graduate degree preferred, bachelors degree required (Economics, Public Policy, Environmental Science, or related discipline). Knowledge of air pollution/climate change policy issues a plus. ABOUT US: E.H. Pechan & Associates, Inc. is an employee-owned technology-oriented consulting firm specializing in a full range of air pollution, information technology, and management consulting services. Classified as a small business, our staff of 20 professionals is located in Pechan's Springfield, Virginia and Durham, North Carolina offices. Pechan offers a competitive salary. Our benefits include medical, dental, long-term disability, and life insurance; personal leave and holidays; 401K, Section 125 flexible benefits plan, and employee stock ownership plan; and educational assistance and professional development. www.pechan.com]]>

<![CDATA[Optical Coherence tomography (OCT) is an exciting non-invasive, cutting edge technology that allows one to evaluate the anatomy and thickness characteristics of the retina in real-time in the living organism. It can be thought of as a form of in vivo histology. Increasingly, optical coherence tomography has been used by clinicians to help diagnose and manage a variety of ocular disorders, including macular degeneration, diabetic retinopathy, and glaucoma, the leading causes of blindness in the United States and around the world. There has been an explosion of interest by pharmaceutical companies to develop new treatments for macular degeneration, diabetic retinopathy, and other retinal diseases. These companies have extensively incorporated OCT as a key retinal imaging modality during conduct of these pharmacological trials. The OCT Reading Center at Duke was founded in 2001 to acquire and interpret OCT images from clinical study sites for sponsored clinical trials, to develop OCT imaging and interpretation protocols that serve as industry and clinical standards, and to produce high quality research data that will favorably impact patient care. We are providing an exciting full-time job opportunity to work as a technical analyst and OCT Reader at the OCT Reading Center at Duke. The work is conducted in an interactive, attractive environment. As a technical analyst, the individual will have responsibilities that include, but are not limited to the following: � Grade OCT images according to OCT Reading Center protocols � Provide feedback to the Senior Technical Analyst, Project Manager and study sites regarding the quality of images submitted. � Help to certify study site OCT technicians. � Perform OCT technician evaluations and prepare OCT technician evaluation reports. � Help to develop and implement policies and procedures as needed. � Assist with standard operating procedure updates as needed. � Help the Senior Technical Analyst to develop and maintain electronic grading systems. � Verify and audit data entered � Perform data entry � Compare and transcribe Reader forms � Enhance and implement the OCT Reading Center at Duke Data Transmission Site (DTS), and train site technicians. � Keep abreast of new developments and techniques in the field and recommend modifications to existing systems as necessary to improve quality and efficiency; and to adapt to specific requirements for clinical and research activities. � Perform other related duties incidental to the work described herein. MINIMUM HIRING SPECIFICATIONS Work requires a Bachelor of Science (or equivalent) degree. Computer literacy is essential, although specific familiarity with OCT is not required. The individual should enjoy interacting with others, like to troubleshoot problems, and be willing to accept new challenges. No phone calls please.Respond to this posting wity your uniquely named CV attached. All submitted CVs and r�sum�s must contain the applicant�s name in the file name. ]]>

<![CDATA[Your Scientific career and its success are dependent upon many factors. Are you in a position to make a strategic contribution? Is your growth supported? Do you get the recognition you deserve? With Manpower Professional, we can get you what you want and we know where to get it. Whether you are pursuing a contract or permanent placement opportunity. You offer your unique skills and experiences. And Manpower Professional offers something unique for you. We're the place for talented individuals who want to do things differently, get ahead and establish a lifelong career. In this contract Lab Technologist position, you'll have the opportunity to: � Perform complex chemical extractions on donor urine, preparing the samples for GC/MS testing. � Maintain current with the lab's SOPs Are you interested? The ideal candidate will possess: � BA/BS degree in a hard science required. Must have 16 hours biology, 16 hours chemistry and 3 hours of math. � Ability to provide education transcripts at time of consideration � Ability to work 3rd shift hours from 11pm - 7:30am Tuesday - Saturday. You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. We've got the right opportunity. Tell us why you're the right person! Apply today. ]]>

<![CDATA[Lab Technologist - You�re precision-oriented, intuitive and a stickler for doing it right. You have working knowledge of biological research and scientific study. You�re a critical thinker who is adept at using logic and reasoning to identify the strengths and weaknesses of alternative solutions. You understand the value of working as a team, yet you function strongly on your own. If this describes you, you�ll want to learn more about this opportunity from Manpower Professional. In this Lab Technologist position, you'll have the opportunity to: - Be involved in assay development and high throughput screening - Design and validate assays for enzymes, receptors, and cellular functions in the metabolic diseases and cancer area. Are you interested? The ideal Lab Technologist candidate will possess: - Broad experience in molecular biology, microbiology or biochemistry - A bachelor's degree in a related field - 1-2 years experience in a lab utilizing molecular and microbial techniques - Experience working with the mammalian cell line You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. We've got the right opportunity. Tell us why you're the right person! Apply today. ]]>

<![CDATA[Your Scientific career and its success are dependent upon many factors. Are you in a position to make a strategic contribution? Is your growth supported? Do you get the recognition you deserve? With Manpower Professional, we can get you what you want and we know where to get it. Whether you are pursuing a contract or permanent placement opportunity. You offer your unique skills and experiences. And Manpower Professional offers something unique for you. We're the place for talented individuals who want to do things differently, get ahead and establish a lifelong career. In this Microbiologist II position, you'll have the opportunity to: � Study growth structure, development and general characteristics of bacteria and other micro-organisms as related to other forms of life. � Perform routine environmental monitoring and assay qualifications. � Water testing such as TOC, conductivity, endotoxin and bioburden. � Follow all established SOP�s and GMP regulations. Are you interested? The ideal Microbiologist II candidate will possess: � BS/BA degree in Microbiologist or related Life Science. � 3-5 years of related microbiology experience in a pharmaceutical lab setting. � Experience with endotoxin and bioburden testing required. You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. We've got the right opportunity. Tell us why you're the right person! Apply today. ]]>

<![CDATA[Heidelberg Engineering is a high tech medical device company which designs, manufactures, and distributes diagnostic instruments for eye care professionals. The company�s products are used around the world by ophthalmologists and optometrists to scan patients� eyes for signs of disease and to assist in the management of patients found to have disease. JOB SUMMARY: This person is responsible for regulatory submissions to FDA and international agencies for medical device clearance, approval and/or licensing as well as for clinical studies related to device. Works closely with others to prepare submissions for new products and product changes as required to ensure timely approval for market release. Interfaces with multiple functional areas, geographies and divisions within the company. This person will serve as the Corporate Compliance Officer. ESSENTIAL DUTIES AND RESPONSIBILITIES: � Prepares, reviews and submits necessary regulatory information to FDA to obtain 510(k) clearance and PMA approval of products. � Coordinates with various functional areas in the preparation, review and submission of IDE applications for clinical studies, as well as other clinical studies including marketing studies. � Reviews all submissions to FDA and international agencies for completeness, truthfulness and compliance with regulations. � Serves as the primary contact to FDA for review of submissions to FDA. � Keeps up-to-date on proposed regulations and guidelines published by FDA and international agencies. � Reviews advertising and promotional material and device labeling for regulatory compliance. � Controls the introduction of product through the United States market through management of the release approval process. � Initiates changes to practices and procedures to support compliance requirements � Brings regulatory and corporate compliance questions/issues to the attention of senior management � Provides general guidance or training support of professional staff. � Provides interpretations & direction to applicable company personnel regarding the regulatory aspects associated with relevant functions. � Acts as Corporate Compliance Officer to review, audit and ensure compliance with corporate compliance policies and procedures. KNOWLEDGE/SKILLS/ABILITIES REQUIRED: � Minimum of BS/BA in scientific or engineering discipline or equivalent combination of education and experience. MS or JD preferred. � 10-15 years of successful experience in related field and successful demonstration of increasing responsibility and accomplishment in the responsibilities described above. � Experience in the medical device industry preferred, but relevant experience in the area of combination products (drug/devices) will be considered. � Demonstrated excellent writing skills in the preparation of technical documents based on technical reports prepared by other technical functions. � A thorough understanding of U.S. FDA regulatory laws and requirements to ensure compliance to regulations without hindering business and growth and understanding of regulatory laws in major international markets. � High levels of professionalism, ethics and compliance in order to interact with FDA and serve as a representative of Heidelberg Engineering. � Strong written and oral communication skills in order to facilitate communications with FDA and minimize unnecessary FDA inquiries. � Advanced degree may be substituted for experience, where applicable. � Approximately 20% of time may require domestic and/or international travel. ** Position will require 1 week per month travel in Germany. � German language ability strongly preferred. ]]>

<![CDATA[8 month temporary position. Please reference #867 on responses/replies. Resumes required to be considered. 1. Test raw materials and release following cGMPs and cGLPs. 2. Test bulk received and release following cGMPs and cGLPs. 3. Perform tests on bulk, such as percent water, percent solids, viscosity, pH melting points, etc. 4. Execute stability protocol(s) for production samples of new products and existing products. 5. Initiatie NCRs for out-of-specification results and complete laboratory investigations. 6. Collaborate with Compounding Department personnel and the Process Engineer to improve BMPs( Bulk Manufacturing Procedures) 7. Maintain all bulk specifications. Revise and update bulk specification history spreadsheet and bulk specifications book. 8. Perform basic microbiological tests and ability to explain results. 9. Write and execute stability protocols 10. Write stability reports and distribute to appropriate personnel 11. Create and revise raw material specifications, finished goods specifications, and 12. Ensure all laboratory equipment is in proper working order and maintain calibrations. Required Skills/Experience 1. BA/BS Degree in Chemistry, Lab Science, Biology or related field required and two (2) years of related experience required OR AA/AS Degree in a related lab science filed required and five (5) years of related industry experience in a research, analytical or Quality Department laboratory required. 2. Proficient computer skills in Microsoft Office. 3. Demonstrated ability in analytical reasoning is required. 4. Demonstrated ability in operating industrial testing equipment, including a penetrometer, melting point apparatus, viscometer, pH meter, GC, HPLC, FTIR, Uv/Vis, Soleris 128 etc. as needed. 5. Demonstrated proficiency in writing and speaking English is required. Must be able to pass drug and background checks ]]>

<![CDATA[Seeking highly motivated individuals with a BS in life sciences/biology and/or chemistry, to work in an applied science group evaluating drug treatments, toxicology, and respiratory biology. The positions require experience in inhalation toxicology, veterinary procedures (all species of laboratory animals), Good Laboratory Practice (GLP), analytical chemistry, and study coordination or management. Good writing and communication skills are required. In addition to animal handling and laboratory functions, areas of responsibility will include project initiation, planning, protocol development, and execution. The chosen candidate must be detail oriented and able to work efficiently in both independent and team environments while under minimal supervision. Relocation assistance available. An EOE employer ]]>

<![CDATA[The Fountaingroup, on behalf of a prominent client, is seeking a Microbiologist to study growth structure, development and general characteristics of bacteria and other micro-organisms as related to other forms of life. Required Qualifications: �Environmental monitoring. �Endotoxin testing. �Water collection. �Bioburden. �Willingness to work some nights and weekends. Interested candidates please submit resumes to CassandraS@thefountaingroup.com. Must have all required qualifications. ]]>

<![CDATA[The Fountain Group is a professional services company and we have an IMMEDIATE contract job opening with one of our clients for a Microbiologist 2 position in Holly Springs, NC. Job Description; DUTIES >> Studies growth structure, development and general characteristics of bacteria and other MICRO-organisms as related to other forms of life. Experienced in performing environmental monitoring and assay qualifications. All other duties as requested. For immediate consideration, please send your resume with job title / location to <a href="mailto:coletteg@thefountaingroup.com" rel="nofollow">coletteg@thefountaingroup.com</a>. The Fountain Group 10012 North Dale Mabry, Suite 211, Tampa, FL 33618 <a href="http://www.TheFountainGroup.com" rel="nofollow">www.TheFountainGroup.com</a> <a href="http://www.TheFountainGroupBlog.com" rel="nofollow">www.TheFountainGroupBlog.com </a>Join us on Linked in at <a href="http://www.linkedin.com/groups?gid=2115943" rel="nofollow">The Fountain Group's Real Time Job Opportunities Group </a>]]>

<![CDATA[Sales Manager- Testing Lab Essential Duties: Implements sales strategies to achieve high performance business results Participates in customer relationship events to build beneficial business partnerships Maintain and build client base through sales calls and other means of communications Plan, budget monitor and report on expenditures in your area of responsibility Attending trade shows within the industry Additional Knowledge and Skills: Experience in aerospace or nuclear industries a huge plus Knowledge of testing lab practice a plus Experience in managing complex business relationships Developed oral and written communication skills to meet variety of communication needs (performance reviews, presentations, employee training and development) Experience Areas: Must have demonstrated success in sales and marketing Must have demonstrated success in writing business and sales plans Must have knowledge of determining pricing for services Must be proficient in standard office software and computer systems Education and Experience level: ]]>

<![CDATA[We are currently seeking a research scientist to help with the rapid development of new biosensors. Specifically we will be looking at teh polymeric materials and focusing on the development of those materials within prototype construction, characterization, and performance. Minimum requirements: -B.S. in organic/polymer chemistry or biology (MS preferred) -1 year of laboratory experience minimum -A basic understanding of fundamental techniques in drug formulation and analysis is required. -Candidate should have 1 year of experience in animal handling and experimental procedures involving animals. -Candidate should be a motivated self-starter and team player with strong written and oral communication skills. This is a 12 month contract position. If you are a local candidate interested in this opportunity - please e-mail your resume and availability for immediate consideration. ]]>

<![CDATA[We are looking for experienced med techs with current phlebotomy experience to work at a biotech R&D lab in Durham, NC. This position will be based in a microbiology lab, however training can be provided to med techs who may not have worked in micro recently. Minimum requirements: 0-2 years work experience -B.S. degree in biology, clinical lab/med technology, etc. -current Phlebotomy experience/certificate/etc. (*This is a MUST HAVE - please do not apply if you do not have this experience*) -willingness to work in micro research & development This is a long term contract position with the possiblity of going permanent. If you are interested - please e-mail a copy of your resume, and include your availability and hourly salary requirements for immediate consideration.]]>

<![CDATA[Busy clinical research group is hiring a Research Assistant to help with the day-to-day activities of several research studies enrolling participants with chronic pain and healthy volunteers. The Research Assistant will perform duties including the following: *Participant recruitment *Phone screening and scheduling of participant appointments *Data collection including blood pressure assessment and sensory testing in accordance with standardized protocol *Blood sample collection *Data entry, filing, preparing research documentation The Research Assistant will work as part of a team conducting multiple research activities. The research assistant must be able to follow strict protocol guidelines. Minimum qualifications include excellent communication and organizational skills; detail-oriented; familiarity with research; strong interpersonal skills; and strong computer skills. Bachelor�s degree in a health-related field required. Phlebotomy experience required and research experience preferred. This is an excellent opportunity for someone preparing to apply for medical, dental or nursing school. ]]>

<![CDATA[POSITION SUMMARY As Clinical Scientist, support the development of one or more oncology programs from pre-phase 1 through phase 3 and global registration. DUTIES & RESPONSIBILITIES Responsible for working collaboratively with the medical lead and team to execute the clinical program(s). Specific role will include some or all of the following responsibilities: Assist in planning, executing and reporting global clinical trials Conduct medical review of adverse events Assist in interpretation of efficacy and safety data from clinical trials Assist in ensuring regulatory compliance for clinical trials and reporting Assist in writing and designing standard protocols and amendments Assist in developing publications, abstracts, presentations, and/or clinical sections of regulatory documents. QUALIFICATIONS Basic qualifications: RN/Pharm.D. or equivalent (BA/BS/Ph.D. may be considered if the candidate has substantial oncology clinical research experience) 2-3 years oncology clinical research experience in an academic or in an industry setting Preferred qualifications: Proven scientific writing skills, with strong inter-personal, written/verbal communication skills Apply Link: <a href="http://bioemployment.jobamatic.com/a/jbb/job-details/198454" rel="nofollow">http://bioemployment.jobamatic.com/a/jbb/job-details/198454</a>]]>

<![CDATA[The Wellington Group has been engaged to find a senior manager to cover both the quality assurance and regulatory affairs departments of a growing medical device group. This position will develop, implement and manage the company�s quality and regulatory strategies. Put your skills and experience to work in a new position! Responsibilities include: � Direct Quality Assurance activities for sourcing of raw materials, product development, manufacturing & characterization � Assure company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products � Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review � Contribute to preparation of CMC sections for IDE and PMA submissions, and international equivalents � Interface with US and International regulatory authorities as necessary � Maintain regulatory procedures and documents to assure continued certification for development, manufacturing, and marketing of products � Work in a cross-functional team and represent Quality at Product Development team meetings � Contribute to the development and implementation of process/methods validation protocols and reports � Audit and oversee activities of contract manufacturers, suppliers and consultants The qualified candidate will have: � 12-15+ years experience within medical/pharmaceutical products quality and regulatory environment � Track record of providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products, including experience with CMC requirements � BS in scientific or engineering discipline, advanced degree preferred � Experience in preparing and obtaining approval of device/drug combination product FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications Industry: Medical Device Job Code: BHJOB3594_225 Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. 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> ) +1 910-338-2795]]>

<![CDATA[The Wellington Group is seeking an experienced Clinical Operations professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market through developing a quality clinical program! The Director of Clinical Affairs is a key management position in the development, research and commercialization of new products. The Director will develop, implement and manage the company�s clinical research strategy. Responsibilities include: � Design and direct the company�s global clinical study strategy to obtain timely regulatory approval of products and acceptance by clinicians � Lead the design of credible clinical studies, integrating inputs from clinical study professionals, clinicians, statisticians, regulatory agencies, and management � Manage contracted Clinical Research and Core Lab staff and other consultants to prepare materials, engage clinicians, conduct studies, compile data, and produce reports on schedule and within budgets � Develop relationships with participating clinicians and clinical research staff to assure effective management and communications � Lead the preparation of the clinical portion of regulatory submissions � Represent the company�s clinical perspective in regulatory agency interactions � Inform senior management of clinical study status and issues � Participate in publication of clinical results The qualified candidate will have: � 10+ years working in clinical study programs in the medical products industry, including at least 4 years managing design and successful completion of clinical studies for device/drug combination products � Demonstrated effectiveness in managing and motivating Clinical Research Organizations � Significant role in directing participating clinicians � Knowledge of international clinical regulatory requirements � Strong planning, communication, and management skills � Preparation of clinical publications � BS/MS in life sciences with training in clinical research � Frequent international travel Industry: Medical Devices, Biologics, Pharmaceutical Location: Either RTP, NC Recruiter: Lisa Job Code: BHJOB3594_220 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> ) +1 910-338-2795]]>

<![CDATA[The Wellington Group is seeking an experienced regulatory affairs professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market! The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization. The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products. Responsibilities include: � Lead a team of regulatory professionals to define and implement the regulatory strategy � Lead the preparation, submission, and timely approval of regulatory applications � Lead the interaction and negotiations with regulatory agencies � Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products � Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends The qualified candidate will have: � 10+ years of Regulatory Affairs experience with at least 4 years of medical devices and 4 years in senior manager � 4-year degree required, graduated degree preferred � Experience in providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products � Experience in preparing and obtaining approval of device/drug combination products � FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications � Significant experience planning for and management of regulatory compliance audits Industry: Medical Devices, Biologics, Pharmaceutical Location: Either RTP, NC or Cambridge, MA Job Code: BHJOB3594_219 Recruiter: Lisa Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. 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]]>

<![CDATA[The Wellington Group has been engaged to find a medical device process and product development engineering professional. This is a great opportunity to work for one of RTP�s growing biotech / medical device companies with a focus on current and future combination technologies. The Senior Process Development Engineer will be responsible for multiple aspects of the development of the company�s product line, from R&D through commercialization. Responsibilities include: � Direct non-clinical testing in compliance with regulatory requirements and standards � Prepare animal and bench test protocols in cooperation with test laboratories � Oversee performance of tests to assure compliance with protocols � Prepare written reports and presentations of test results suitable for submission to regulatory agencies � Manage development of terminal sterilization process � Manage development of commercial packaging with contract design/assembly firm � Coordinate development/test activities with multinational suppliers for product improvements � Reports to the Director of Development The qualified candidate will have: � Demonstrated success in developing implantable medical products through commercialization � Proficient in managing animal and bench test programs: Protocol preparation, directing testing, completion/presentation of reports for regulatory agencies � Highly skilled at managing test laboratories and product suppliers � Capable of managing multiple tasks simultaneously to meet schedules and budgets � Must understand statistical analysis and use CAD software � 10+ years experience in medical device development/testing, including implantable products � BS (or higher) in engineering/science Industry: Medical Device, Biotechnology, Combination Products Job Code: BHJOB3594_258 Recruiter: Lisa Permanent position with an exciting new medical technology company offering great benefits, salary, bonus and relocation assistance. 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> ) +1 9103382795]]>

<![CDATA[SUMMARY: A Chemist I is expected to apply their knowledge to the solution of routine problems. They will use and interpret written documentation. The work will require the exercise of discretion and judgment in making independent choices in significant matters. The following essential duties and responsibilities are required. ESSENTIAL DUTIES AND RESPONSIBILITIES: � Work to meet the lab�s goals and clients� holding times and due dates. � Communicate with supervisor, team members, others applicable, concerning projects, instrument(s) status, the process, and other issues. � Operate and maintain specific instruments in assigned work area. � Read, understand, apply and communicate written and verbal information regarding the handling, management and processing of samples within clients� projects. � Review project folders; reading and following special instructions to be sure that work is performed properly. � Prepare or review project paperwork, providing documentation which is in compliance with Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs) � Follow and help revise Standard Operating Procedures (SOPs). � Promote team building, safety, quality and productivity throughout the laboratory. � Participate in method development and special projects if applicable. � Label all laboratory containers (including, but not limited to Hazardous Waste) properly following GLPs and GMPs � Read, understand, apply and communicate written and verbal information regarding the handling, management and transportation of hazardous waste within the laboratory. � Perform computer functions required to complete duties and responsibilities. � Be aware of and comply with all policies and procedures described in the Policies and Procedures Manual. � Perform other duties as assigned. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ]]>

<![CDATA[REGULATORY AFFAIRS SPECIALIST________________________________________ Gorbec Pharmaceutical Services is privately owned, emerging pharmaceutical development laboratory and small scale manufacturer. Located in the RTP area of North Carolina, the company is building a top quality business to meet the needs of the growing pharmaceutical industry. This young company has a professional, high energy atmosphere and has been a rewarding place for current employees to work. The company places value on and rewards exceptional performance and a commitment to quality. Essential Duties and Responsibilities: Regulatory Affairs Specialist provides support to regulatory department through activities including but not limited to, providing guidance to personnel and reviewing of product labeling and submissions. The Regulatory Affairs Specialist also maintains regulatory compliance for plant operations and minimizes adverse customer or government actions. Where appropriate, the Regulatory Affairs Specialist advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality. In addition, and specifically: � Promoting quality achievement and performance improvement throughout the organization; � Liaises with regulatory agencies and various internal functions � Coordinates, prepares, and reviews all appropriate regulatory submissions and supplements � Post Marketing Studies � Annual Product Reviews � Coordinates and reviews development of promotional labeling with Marketing � Ensures SOPs and regulatory guidelines are developed and implemented � Labeling and packaging review and approvals � Assist in compliance programs including internal, external and third party audits � Guidance and support to new product development teams � Other duties, as assigned, or as business needs require Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties required of this position, the individual will be required to access all areas of the laboratory. The position may also require wearing lab coats, gloves, safety glasses or shields, Tyvek suits or other personal protective equipment. Travel: This position will require occasional travel to conferences, trade shows, and client sites. EDUCATION AND/OR EXPERIENCE: Bachelor�s Degree in science preferred and 0-6 years experience in Regulatory Affairs. Previous labeling and ANDA filing experience required. ]]>

<![CDATA[Research Associates Needed: Process Development � Durham, NC A well-established contract manufacturing company is seeking research associates in their process development group. It is this company�s employees who help keep them on the cutting edge of contract manufacturing, and as a research associate for process development, you will work closely with leading drug discovery companies in a production-scale, cGMP facility. This company is looking for research associates in both upstream and downstream processing. Job Responsibilities include, but are not limited to: - Handling downstream operations such as mixing, filtration and ultrafiltration and their associated equipment preparation, setup and applications. - Assisting in process equipment maintenance and preventive maintenance, calibration tasks and documentation. - Performing scientific tasks related to fermentation and recovery in support of process development and/or scale-up operations - Performing in-process analytical testing using column chromatography supporting upstream biomanufacturing operations - Collaborating with other process development groups to address their needs for timely turnaround of assay requests - Participating in regular group and departmental meetings to address issues related to laboratory operation and data analysis Job Requirements Include: - B.S. or M.S. in Biology or related field required - Experience with downstream or upstream processing is preferred; as well as, experience within a GMP environment This is currently a three to four month contract position with first shift hours (M � F, 8AM � 5PM). Pay rate is dependent on experience. For immediate consideration, please apply online at www.kellyscientific.com, or email your resume to 4531@kellyservices.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 ]]>

<![CDATA[A NC Triad Company seeks a leader for their Quality Program who has 5+ years experience in either tissue,or medical devices with significant knowledge and experience in FDA regulatory standards. Must be able to read, understand and interpret FDA standards, maintain and bring products into compliance with these standards. This is a full time staff position and a BS Degree is required. The ideal candidate will have worked in the medical device, or tissue bank industries and will be able to competently apply the regulatory rules to the company's diversified service and product environment. The right candidate will be a doer that while focusing on compliance, can still be nimble enough to be responsive to new opportunities. This individual must establish a quality control program for the company which recognizes that it is a time sensitive production logistics operation. Responsibilities associated with this position include: Managing laboratory activities and associated projects including assignment, organization, and tracking. Monitoring of overall activities within the laboratory, including active participation in development of products. Compilation, analysis and graphing data for all laboratory functions. Assuring adherence of acceptable industry practices including: GMP's, GTP's, USP, QSR by staff during execution of all tasks. Evaluation, review, mentor, train and manage personnel performance. Review/Approve laboratory documentation, complaint and failure investigations, and laboratory studies. Planning and organizing projects required to achieve group and corporate objectives. Participation in budget process, monitoring group spending. Including cost analysis/cost reduction. Serve as a technical expert on methods preformed in the group; participate in cross-functional teams to accomplish business objectives. Ensuring efficient functioning of tissue processing activities. Preparing reports to inform management on quality issues. Leading the development and validation of methods used for testing. Acting as a Change Agent with the ability to influence at all levels of the organization. Qualifications: BS in Engineering or life sciences (preferred) or allied fields with a minimum of 5 years experience in regulatory compliance, regulatory affairs and quality systems in the tissue banking and/or medical device industry. Solid experience and proven track record in FDA successful submissions of 510k, IDE and PMAs. Exhibited project management and leadership skills. Demonstrated leadership, communication and presentation skills. PC and / or Macintosh computer literate, Working knowledge, Windows/Mac OS, MS Office Suite. Must be able to lift/carry 25-30 lbs; Wear gloves, face masks, respirators, and clean room attire. Knowledge of applicable testing and/or calibration equipment. Salary is dependant upon experience. Resumes in Word format only to noted e-mail address.]]>

<![CDATA[Are you seeking to expand your knowledge and join a goal oriented team? Kelly Scientific Resources is currently seeking Quality Control Chemists for a solid-dose pharmaceutical manufacturer in Wilson, NC. This company is consistently involved in some of the most innovative research within the pharmaceutical industry and is often seen as a leader in its field. Primary responsibilities for this position include: - Handling instrumental analysis of stability samples (solid-dosage forms) - Cleaning and processing validation - Investigation of analytical problems - Preparing accurate documentation. The ideal candidate will also have experience in analytical instrumentation troubleshooting, HPLC & GC, dissolution testing, auto sampler dissolution, disintegration, and Karl Fischer. Familiarity with cGMP & USP/NF is also important. This position requires a Bachelor's Degree in Chemistry, with at least six months of industry experience. For immediate consideration, please email your resume to 4531@kellyscientific.com or call Kim Shearer at (919)467-1752. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at: www.kellyscientific.com ]]>

<![CDATA[Our client, a high-quality, niche Contract Research Organization (CRO) in the RTP area, is actively recruiting for a very sharp and skilled Biostatistician for key role on its outstanding team. This person can work in either the Triangle or Wilmington office and, although the position is full-time, hours can be very flexible. Company is experiencing significant growth and long-term prospects are equally promising. It has earned a superb reputation for quality and service delivery and seeks a top-notch biostatistician who can further this reputation. This Biostatistician will lead the statistical work related to assigned client accounts including: o Development and review statistical analysis plans as well as analysis of results. Development, maintenance and production of statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. Ensuring the efficiency, quality, and integrity of data reporting, project and supervisory activities executed. In addition, this biostatistician will be act as a key client interface as well as be responsible for controlling assigned projects. Excellent technical skills must be complemented by seasoned organizational skills and interpersonal savvy. Ideal candidate will offer MS or PhD (preferred) in Statistics/Biostatistics and 2+ years handling similar work in clinical research. Further, seek a technician with business savvy; one who works exceedingly well in an independent, but collaborative, highly-empowered setting. This is an excellent opportunity for an industry star who thrives in a �client-first�, �quality over quantity� organization. Many more details are available. Please forward Word resume for prompt reply. Local candidates please. Visa sponsorship is not available at this time. ]]>

<![CDATA[Essential Duties and Responsibilities: This position is a bench scientist. Genetic analysis using the Affymetrix arrays (DMET, 3� IVT and whole transcript gene expression arrays). *Excellent skills in experimental design, implementation, troubleshooting, and data analysis. *Experience handling large datasets generated from DNA and/or Microarray analysis. *Performs RNA extraction, total RNA quality analysis and cDNA synthesis from a variety of sources including FFPE tumor samples using approved standard operating procedures. *Perform absolute and/or relative quantification of gene expression levels using real-time PCR methods. *Review of gene expression data, gene expression protocols and final reports. *Performs DNA purification and quantification, gel electrophoresis, and normalization. *Performs routine and non-routine genotyping assays including DNA sequencing, gel based assays and endpoint analysis. *Performs the laboratory portion of the assay design and development and validation process with including optimization of PCR conditions. *Assay design for the detection human genetic variations using bioinformatic software and other appropriate resources. *Perform literature searches in support of the scientific efforts at Gentris. *Develops protocols and methods for evaluating and analyzing various types of genomics data. *Assists in the writing, editing, and implementing standard operating procedures, material requirements documents, and other essential documentation. *Mentoring and training staff in the junior scientists positions. *Communicate ongoing project/study progress and act as the key interface to clients. Minimum requirements include a Biological Science degree (BS+4, MS+2) with Industry experience, Biotech / Pharmaceutical / Drug Discovery. Candidates must have working experience with molecular biology techniques, and knowledge of advanced molecular biology techniques especially with RNA and microarray chip technology. Must be detail-oriented. Ability to think and work independently. ]]>

<![CDATA[� Processes client samples using approved standard operating procedures � Performs routine and non-routine intermediate to high complexity pharmacogenomic assays in a GLP regulated environment including DNA purification and quantitation, gel electrophoresis, real-time PCR, and DNA Sequencing � Perform RNA extraction, cDNA synthesis and total RNA quality analysis from a variety of sources including FFPE tumor samples using approved standard operating procedures � Absolute and/or relative quantification of gene expression levels using real-time PCR methods � Review of gene expression data, gene expression protocols and final reports � Ability to perform quality work in a RNase-free environment � Perform the laboratory portion of the assay development and validation process with minimal supervision including optimization of PCR conditions � Work is consistently high in quality � Assess and prioritize daily activities and communicate/update study directors and the Lab Manager as necessary � Assists in identifying and troubleshooting discrepancies and quality control failures � Assists in the writing, editing, and implementing standard operating procedures, material requirements documents, and other essential documentation � Assists in the development and validation of new assays � Maintains equipment logs, maintenance logs, and calibration logs � Assists in laboratory inventory, makes common reagents and reviews reagent quality control Requires a minimum of a Bachelor�s Degree with a concentration in life sciences, Molecular Biology, Biochemistry, Pharmacology, or closely related field. Must be able to multitask and have good time management skills. Must be able to work in a team atmosphere, have experience in aseptic techniques, and have a positive attitude toward work environment. ]]>

<![CDATA[We are currently seeking an experienced QC Tech or QC Chemist for a position within our group. This person will be responsible for following SOP's and methods to conduct GC and HPLC testing. Requirements: * Bachelor's degree in technical field * GC and HPLC experience * 2 to 7 years experience in a QC Lab * Pharma background a huge plus Qualified candidates please send resumes to chrisc@thefountaingroup.com]]>

<![CDATA[We have a Contract opportunity with a prominent client for an Associate QC Chemist in Wilson, NC. DUTIES Follows established standard operating procedures and methods to conduct analytical testing within workgroup. Maintains laboratory documentation, test procedures, raw data and final results in accordance with regulatory guidelines and Company SOPs. SKILLS GC and HPLC Experience EDUCATION Bachelor's degree or technical equivalent and some related experience and three to five years related experience in a QC Lab, preferably for a pharmaceutical company. For immediate consideration, please forward a current copy of your Word formatted resume to jason@thefountaingroup.com. ]]>

<![CDATA[Qualified candidates please send a copy of your resume to: juang@thefountaingroup.com -- DUTIES AND RESPONSIBILITIES DUTIES >> Follows established standard operating procedures and methods to conduct analytical testing within workgroup. Maintains laboratory documentation, test procedures, raw data and final results in accordance with regulatory guidelines and Company SOPs. Entry level position. Work is assigned and supervised by a Chemist, with detailed instructions given and work generally reviewed upon completion. Grows to demonstrate understanding of company policies and standard practices to resolve problems. Analyzes issues and uses judgment to make decisions in conjunction with lab management. SKILLS >> GC and HPLC Experience ]]>

<![CDATA[The Fountain Group is a professional services company and we have an IMMEDIATE contract job opening with one of our clients for a QC Chemist DUTIES >> Follows established standard operating procedures and methods to conduct analytical testing within workgroup. Maintains laboratory documentation, test procedures, raw data and final results in accordance with regulatory guidelines and Company SOPs. Entry level position. Work is assigned and supervised by a Chemist, with detailed instructions given and work generally reviewed upon completion. Grows to demonstrate understanding of company policies and standard practices to resolve problems. Analyzes issues and uses judgment to make decisions in conjunction with lab management. SKILLS >> GC and HPLC Experience EDUCATION >> Bachelor''s degree or technical equivalent and some related experienceand three to five years related experience in a QC Lab, preferably for a pharmaceutical company. For immediate consideration, please send your resume to: randys@thefountaingroup.com ]]>

<![CDATA[Kelly Scientific Resources is currently seeking an experienced import/export specialist for a pharmaceutical company in RTP, NC. This opportunity is in the import/export services team with a company that is consistently involved in some of the most innovative research within the pharmaceutical industry. This is a contract position that is currently approved through September 2010. The work schedule is Monday through Friday, 8:00AM to 5:00PM. RESPONSIBILITIES include: - Providing guidance to internal customers, foreign affiliates, overseas suppliers, and external service providers - Supporting imports of drug substances, drug products and components for research, development, and medical customers - Assigning Customs tariff numbers and other regulatory information to support imports into multiple countries - Evaluating pharmaceutical finished products and technical equipment to determine Customs classifications - Preparing and/or distributing international trade documentation to facilitate US and foreign Customs clearance - Auditing import documents for compliance with US Customs regulations REQUIREMENTS include: - Two years of job-related experience - Background in chemistry, pharmacy, pharmaceutical development, or chemical development - Understanding of US Customs Harmonized Tariff schedule - Understanding of chemical function groups and pharmaceutical indications - Customer focused perspective with strong communication skills Please apply online at www.kellyscientific.com or send resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at www.kellyscientific.com ]]>

<![CDATA[**Please note that this is a 1 year contract position** Description: Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples. Interprets compendia and internal monographs, NDAs and Quality Standards. Requirements: BS/MS IN SCIENCE, preferably in Chemistry or Biology, with 1-2 YEARS OF with Pharmaceutical Laboratory Experience. Basic knowledge of analytical instrumentation with strong technical and interpersonal skills. Strong working knowledge of raw materials, KF, Dissolution, HPLC (Waters) is preferred. ]]>

<![CDATA[Key Responsibilities: � Reviews and issues batch record materials � Conducts batch record review for clinical approval � Performs QA functions for manufacturing activities � Will be involved in documentation management to include SOPs, batch records, protocols, validations and complaints � Assist in deviation and CAPA review � Assist in implementing and maintaining the quality systems programs for the Durham site including but not limited to exception management, document control, supplier qualification, and internal and external audit program. � Assist in the development, review, and revision of standard operating procedures for the Durham manufacturing site. � Perform internal audits to include reports and assisting departments with gap remediation. � Other duties as assigned Qualifications: � Requires a bachelor�s degree in a scientific related field. � 1 + years of relevant pharmaceutical industry experience in a cGMP environment. � A working knowledge of either US FDA or EU and GMP regulations is required. � Ability to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally. � Working knowledge of word processing, spreadsheets and email software. � Must be detail oriented, self motivated, organized and have the ability to prioritize work. � Ability to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situation and deadlines. ]]>

<![CDATA[Environmental Laboratory Supervisor **PLEASE include a current resume when you respond. Requirements -Experience with below responsibilities -Bachelor�s degree in Chemistry or related scientific discipline combined with 5+ years experience OR 10+ years laboratory experience with no degree -Previous supervisory experience a MUST -MUST have experience with semi-volatile organic compounds in an environmental setting--this is non-negotiable -Strong verbal and written communication skills -Basic math and reasoning skills Responsibilities -Oversee day to day management of laboratory and supervise laboratory staff -Adhere to budget guidelines and meet set goals -Review analytical data to ensure accuracy and compliance with quality standards; Prepare and deliver analytical reports in a timely manner -Conduct performance reviews and interviews for potential hires -Lead training of personnel -Assist in building of annual budget -Continually look for ways to improve efficiency and productivity in lab -Ensure compliance with company policies and SOPs -Motivate staff and promote high level of morale ]]>

<![CDATA[Description: Our client is a biotechnology company focusing on the development of treatments for chronic and life-threatening diseases. Opportunity Statement: The Senior Regulatory Affairs Specialist is responsible for preparing and managing regulatory submissions. This role participates in all aspects of regulatory affairs, including liaising with federal regulators (CBER) and will act as a resource for less senior regulatory team members and personnel from other departments. Responsibilities: - Prepare and maintain new and existing regulatory applications including initial applications (INDs, CTAs, BLAs, MAAs, etc.), amendments, supplements, variations, and other submissions in compliance with health authority regulations - Maintenance of regulatory files - Support of product registrations and post-approval compliance - Responsibilities include the regulatory aspects of annual reports, quality updates, protocol revisions, labeling updates, pharmacovigilence submissions, and labeling, advertising, and promotional material submissions - Assist project teams with electronic submission requirements - Interact with various regulatory agencies, contract groups, and partner organizations to carry out regulatory functions - Support other regulatory and compliance activities as required - Work with other resources to ensure international regulatory compliance and submission consistency Qualifications & Characteristics: - Bachelors level degree in a scientific related field - Advanced scientific degree (Ph.D. or PharmD) preferred - 10+ years of relevant drug development industry experience - Biologics (BLA's) required - Experience with post-marketing related regulatory activities - Strong knowledge of US FDA and EU regulations - Electronic submissions experience is highly desireable - Passion, energy, personal drive, and motivation - Outstanding leadership and communication skills We will only be able to respond to those inquires who meet the stated requirements. Please include the position ID "CC-1579" in the subject line of your correspondence. Please forward your credentials in confidence to: recruiter2@ccesearch.com (Word format please) To review additional opportunities, please visit our website at: www.ccesearch.com ]]>

<![CDATA[The Fountain Group is a professional services company and we have an IMMEDIATE contract job opening with one of our clients for a --insert position-- position. Job Description; The applicant should have a Ph.D. or Masters with significant knowledge of plant biology, eukaryotic expression control, gene expression in heterologous systems, plant cell culture and general molecular biology. Other valuable experience would include: plant anatomy & physiology, genetics, plant breeding, and biochemistry. For immediate consideration, please send your resume with job title / location to <a href="mailto:coletteg@thefountaingroup.com" rel="nofollow">coletteg@thefountaingroup.com</a>. The Fountain Group 10012 North Dale Mabry, Suite 211, Tampa, FL 33618 <a href="http://www.TheFountainGroup.com" rel="nofollow">www.TheFountainGroup.com</a> <a href="http://www.TheFountainGroupBlog.com" rel="nofollow">www.TheFountainGroupBlog.com </a>Join us on Linked in at <a href="http://www.linkedin.com/groups?gid=2115943" rel="nofollow">The Fountain Group's Real Time Job Opportunities Group </a>]]>

<![CDATA[The Fountain Group is a professional services company and we have an IMMEDIATE contract job opening with one of our clients for a Molecular Biologist. A highly motivated individual for a Molecular Biologist Post-doctoral/Masters research associate position. The incumbent is expected to develop expression systems useful to investigate plant development and regulation. This position will be a part of a working group using molecular technologies to enable gene discovery platforms and interact with several key teams that move discoveries to products. The incumbent will be expected to comply with all corporate and governmental regulations and actively secure intellectual property. Representative activities include: (1) Developing project plans based on business strategy (2) Reviewing relevant publications and patent literature (3) Designing experiments and establishing protocols (4) Interpreting and communicating results (5) Working closely with other scientists to achieve common goals (6) Making team decisions on technical outcomes The applicant should have a Ph.D. or Masters with significant knowledge of plant biology, eukaryotic expression control, gene expression in heterologous systems, plant cell culture and general molecular biology. Other valuable experience would include: plant anatomy & physiology, genetics, plant breeding, and biochemistry. For immediate consideration, please send your resume to: randys@thefountaingroup.com ]]>

<![CDATA[Client Description: Our client is a drug development services organization with a tradition of delivery of quality results to its clients. Opportunity Statement: Are you an experienced investigator seeking to broaden your operational experience with large federally funded trials? This key position will direct multi site, multi protocol clinical trials. Responsibilities: - Serves as PI for coordinating centers of multi-site projects - Senior leadership for all aspects of the project including study design, protocol development, study implementation, preliminary and final data analysis, and presentation of study results - Drives decision-making regarding research priorities of company or department, and provides information on feasibility of prospective projects - Develops research plans, designs experiments, outlines research procedures to be followed, and identifies and/or provides training to subordinate personnel to carry out research - Plans schedule of research according to established project plans and establishes daily or weekly routines necessary to meet project timetable - Monitors study resources and budgets - Prepares reports and papers of completed projects for publication in scientific journals, presentation to regulatory agencies or at conferences, or use in further research activities Qualifications: Education/Certifications - - Ph.D. or MD Professional Qualifications - The successful candidate will have: - Prior experience and a demonstrated track record as a Principal Investigator with scientific knowledge, education and/or work history in epidemiology, pharmacology and/or statistics - 10 years or more experience serving as Principal Investigator or similar capacity - Prior experience leading large staff sizes of 25 FTE�s or more - Substantial experience leading coordinating centers - Prior experience on studies with more than a dozen protocols - CV with a substantial number of peer-reviewed publications including �1st author� publications - Experience in working with clients that fund research in public health, including federal agencies, private foundations, and/or the commercial sector Characteristics: - Demonstrated influencing and negotiating ability - Ability to travel up to 50% of the time - Self-starter - Excellent attention to detail - Passion, energy, personal drive and motivation - Outstanding written, oral, organizational, and interpersonal skills are required As a professional search firm, we will only be responding to those inquiries that most closely align with the stated requirements. Moreover, our client employer can only review candidates with valid US work authorization at this time. Please include the position ID "CC 1735" in the subject line of your correspondence to ensure review and forward your credentials (*Word format please), in confidence, to: recruiter2@ccesearch.com General CV/resume submissions for inclusion in our knowledgebase of future opportunities can be made to: resume@ccesearch.com For our most recent searches, please review our web site at: www.ccesearch.com ]]>

<![CDATA[Your Scientific career and its success are dependent upon many factors. Are you in a position to make a strategic contribution? Is your growth supported? Do you get the recognition you deserve? With Manpower Professional, we can get you what you want and we know where to get it. Whether you are pursuing a contract or permanent placement opportunity. You offer your unique skills and experiences. And Manpower Professional offers something unique for you. We're the place for talented individuals who want to do things differently, get ahead and establish a lifelong career. In this Molecular Biologist position, you'll have the opportunity to: � Develop expression systems useful to investigate plant development and regulation. � Enable gene discovery platforms and interact with several key teams that move discoveries to products. � Review relevant publications and patent literature, interpret and communicate results. � Comply with all corporate and governmental regulations and active secure intellectual property. Are you interested? The ideal Molecular Biologist candidate will possess: � PhD is required with significant knowledge of plant biology. � Experience with eukaryotic expression control, gene expression, plant cell culture and general molecular biology techniques. You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. We've got the right opportunity. Tell us why you're the right person! Apply today. ]]>

<![CDATA[The Fountain Group is a professional services company and we have an IMMEDIATE contract job opening with one of our clients for a Molecular Biologist. Job Description: Seeking a highly motivated individual for a Molecular Biologist Post-doctoral research associate position. The incumbent is expected to develop expression systems useful to investigate plant development and regulation. This position will be a part of a working group using molecular technologies to enable gene discovery platforms and interact with several key teams that move discoveries to products. The incumbent will be expected to comply with all corporate and governmental regulations and actively secure intellectual property. �Developing project plans based on business strategy �Reviewing relevant publications and patent literature �Designing experiments and establishing protocols �Interpreting and communicating results �Working closely with other scientists to achieve common goals �Making team decisions on technical outcomes Job Requirements: �The applicant should have a Ph.D. with significant knowledge of plant biology, eukaryotic expression control, gene expression in heterologous systems, plant cell culture and general molecular biology. �Other valuable experience would include: plant anatomy & physiology, genetics, plant breeding, and biochemistry. If qualified, please respond with an updated MS Word version of your resume. Dillon Ford The Fountain Group 10012 North Dale Mabry, Suite 211, Tampa, FL 33618 dillonf@TheFountainGroup.com Join us on Linked in at The Fountain Group's Real Time Job Opportunities Group ]]>

<![CDATA[Do you have a Bachelor�s degree in Biology? Are you looking to further your career? Kelly Scientific Resources is currently seeking an experienced Biologist for a pharmaceutical company in RTP, NC. This opportunity is in drug discovery research for diabetes and metabolic disorders with a company that is consistently involved in some of the most innovative research within the industry. RESPONSIBILITIES include: - Design and conduct experiments for evaluating drug effects - Animal drug administration and sample collection - Animal handling - Analyzing experimental data - Maintaining lab notebooks and accurate record keeping REQUIREMENTS include: - Bachelors Degree in the Biological Sciences - At least three years of experience with in vivo physiological and/or pharmacological studies - Strong fundamental understanding of animal biology This is a year long contract position with a Monday through Friday, 8:00AM to 5:00PM work schedule. Please apply online at www.kellyscientific.com or send resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources� (KSR) provides consultative scientific staffing solutions for a broad spectrum of industries on a temporary, project, temporary-to-fulltime, and direct hire basis. KSR is the specialized scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. Since 1995, KSR has grown to over 100+ locations in North America, Europe and the Pacific Rim which are staffed with industry professionals who are scientists themselves. For more information visit us at www.kellyscientific.com ]]>

<![CDATA[1 year contract position We are seeking a highly motivated individual for a Molecular Biologist Post-doctoral research associate position. The incumbent is expected to develop expression systems useful to investigate plant development and regulation. This position will be a part of a working group using molecular technologies to enable gene discovery platforms and interact with several key teams that move discoveries to products. The incumbent will be expected to comply with all corporate and governmental regulations and actively secure intellectual property. Representative activities include: (1) Developing project plans based on business strategy (2) Reviewing relevant publications and patent literature (3) Designing experiments and establishing protocols (4) Interpreting and communicating results (5) Working closely with other scientists to achieve common goals (6) Making team decisions on technical outcomes The applicant should have a Ph.D. with significant knowledge of plant biology, eukaryotic expression control, gene expression in heterologous systems, plant cell culture and general molecular biology. Other valuable experience would include: plant anatomy & physiology, genetics, plant breeding, and biochemistry. If interested, please send Word formatted resume.]]>

<![CDATA[$17.50 - 25 hr pay rate Post-doctoral research associate One year contract! Job Description: Molecular Biologist Post-doctoral research associate position. The incumbent is expected to develop expression systems useful to investigate plant development and regulation. This position will be a part of a working group using molecular technologies to enable gene discovery platforms and interact with several key teams that move discoveries to products. The incumbent will be expected to comply with all corporate and governmental regulations and actively secure intellectual property. Representative activities include: (1) Developing project plans based on business strategy (2) Reviewing relevant publications and patent literature (3) Designing experiments and establishing protocols (4) Interpreting and communicating results (5) Working closely with other scientists to achieve common goals (6) Making team decisions on technical outcomes The applicant should have a Ph.D. with significant knowledge of plant biology, eukaryotic expression control, gene expression in heterologous systems, plant cell culture and general molecular biology. Other valuable experience would include: plant anatomy & physiology, genetics, plant breeding, and biochemistry. ]]>

<![CDATA[Seachaid Pharmaceuticals, Inc. is a product-based company that discovers and develops therapeutic agents to treat human diseases. The approach incorporates rational design with emphases on synthetic, medicinal, formulation and analytical chemistry to generate candidates for drug development. Description: The primary responsibilities of the Formulation Scientist will be to develop solid, semi-solid, and liquid oral dosages for drug candidates for in vivo formulation screening and clinical development. The scientist will develop acceptable prototype oral dosages for in vitro and in vivo testing. The scientist will develop lab scale processes for the selected dosages for transfer to contract manufacturing sites for clinical manufacturing. As a key player in a multidisciplinary team, the Formulation Scientist will interact with analytical, scale-up, and development staff as well as contract research organizations and academic and corporate collaborators as needed for progression of the project. Requirements: One position is available. Applicants with a Ph. D. degree from an accredited institution in Chemistry or Pharmaceutics or in a relevant field of discipline and with three to five years relevant industry experience, an M. S. degree with at least five years relevant industry experience, or a B. S. degree with at least seven years relevant industry experience in the area of oral dosage formulation development are encouraged to apply. The candidate must display creativity and problem solving ability in the area of solid, semi-solid, and oral suspension formulation designs and in establishing acceptable lab scale process for oral dosages. The candidate must be proficient in tablet and capsule dosage forms development and in analytical chemistry, including the use of such tools as HPLC, dissolution apparatus and apparatus relevant to making tablet/semi-solid dosages. The successful candidate will display excellent communication skills in English. Proficiency with relevant computer software is essential. Familiarity with controlled release dosage, solution kinetics and pharmacokinetics are a plus. ]]>

<![CDATA[Our client is seeking a couple of Lab Assistants for residue analysis for plant/soil/animal and water matrices with established methodologies; and e-fate metabolism studies Education / experience desired: new graduate or 1-2 years experience with bachelor degree in chemistry Equipment skills: desire skills: wet chemistry, GC/MS, LC/MS/MS, HPLC; LSC radiochemistry Please send Word formatted resume with contact information if you are interested and feel you are qualified]]>

<![CDATA[HS Diploma/ GED, Clean Criminal Background, Prior experience in the chemical manufacturing area. Bio Tech degree a plus. Must be able to work rotating 12 hr/ swing schedule. 8am- 8pm for two weeks on days: 8pm-8am for two weeks on nights, Must be able to work every other weekend, Must be able to work holidays that fall on the shift schedule. Looking for a team player, Must be good in math and have mechanical ability. Will Prepare raw materials for use in process equipment and operate all process equipment. Will take sterile and production samples. Analyze samples in the production laboratory and take action based on the obtained results. Will complete log sheets and other data sheets neatly and accurately, Must be able to lift raw materials in bags of 50 pounds. Will move and pull hoses weighing up to 20 pounds. Climb stairs frequently during each shift. Must be able to bend, and turn valves using tools such as wrenches.]]>

<![CDATA[Seeking professionals with 0-2 years of experience in environmental science, industrial hygiene or occupational safety to support our office in Morrisville, NC. Position will require some travel. Experience in conducting Phase 1, Transaction Screenings, indoor air quality, industrial hygiene assessments, asbestos inspections and lead based paint inspections/risk assessments preferred. Recent graduates with extensive coursework in life sciences, safety, math, or engineering will find environmental consulting to be an extension of the classroom experience and a chance for application of scientific principles. EI offers an excellent benefit package. Salary commensurate with experience. If you are interested in becoming a contributing member of our team, please forward your resume to cmurray@ei1.com. Please visit our website at www.ei1.com to learn more about EI. The EI Group (EI) is a full-service professional environmental, safety, industrial hygiene, occupational health, and engineering consulting firm headquartered in Research Triangle Park, Morrisville, North Carolina. EI employs approximately 125 people corporate-wide, with branch offices strategically located in Richmond and Roanoke, Virginia, Greenville, South Carolina, Charlotte, North Carolina, Louisville, Kentucky , Florida, and Texas although we routinely provide services for our clients throughout the United States. ]]>

<![CDATA[The EI Group, a full service environmental and occupational health & safety-consulting firm providing services to the banking, commercial real estate, industrial, and utility markets is looking for you! EI�s unique compliment of services has and continues to fuel our growth and expansion; providing opportunities for professional growth for those who are eager to accept responsibility and accelerate their careers. The EI Group (EI) is headquartered near Research Triangle Park, North Carolina. EI employs approximately 125 people corporate-wide, with branch offices in Richmond and Roanoke, Virginia, Greenville, South Carolina, Charlotte, North Carolina, Louisville, Kentucky and Dallas, Texas. Our staff primarily services clients in the southeast, however, we routinely provide services for clients throughout the continental United States as well as internationally. Presently, we are searching for qualified candidates in the following area: Industrial Hygiene, Safety and Training Professional - EI has an opening for an Industrial Hygiene, Safety and Training Professional with previous consulting experience in our Morrisville, NC office. Industrial hygiene sampling, performing safety audits, developing programs, and health and safety training experience are required. A degree in Occupational Safety, Industrial Hygiene, or a related life science degree is also required. Some travel is required. The successful candidate will have 5-10 years of experience in the areas described above as well as a proven record of accomplishment of building business relationships and developing successful technical and cost proposals. Salary and benefits commensurate with experience. If you are interested in becoming a contributing member of our team, please forward your resume and letter of interest to cmurray@ei1.com. You are encouraged to visit our website at www.ei1.com to learn more about The EI Group. ]]>

<![CDATA[Kelly Scientific Resources currently has a long-term contract opportunity for Laboratory Technician within a Laboratory Support Services group of a major pharmaceutical company. We are currently seeking a bright, hard-working, and reliable individual ready to work in a high-throughput, fast-paced laboratory. This opening has a Monday - Friday, 8:00AM-5:00PM work schedule. Job Duties: - Support various departments through reagent and solution preparation - Work with a variety of chemicals to create both small and large volume solutions - Perform wet chemistry related laboratory tasks - Follow proper procedures for notebook documentation and waste disposal - Interact with managers and end-users to coordinate requests Requirements: - BS in Chemistry, Biology, or related field - At least one year of laboratory experience preferred - Previous experience demonstrating customer service skills - Responsible for following SOPs to maintain cGMP compliance Please apply online at www.kellyscientific.com or send resume to 4531@kellyscientific.com for immediate consideration. Kelly Scientific Resources is a highly specialized and rapidly expanding business unit of global staffing provider, Kelly Services, Inc. Kelly Scientific Resources leads the world in dedicated scientific and clinical research staffing, maintaining more than 100 company-owned and operated offices in 19 countries throughout North America, Europe, and the Pacific Rim. Since its launch in 1995, Kelly Scientific Resources has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Visit www.kellyscientific.com.]]>

<![CDATA[This Raleigh medium sized organization is seeking a strong leader in the medical device arena. The responsibilities for this role are as follows: - Manage the operations of this medium sized medical device organization - Manage the scientific development as well as the clinical process for highly complex studies - Work closely with the Executive team in order to strategize on the next steps for the organization - Ability to manage several projects simultaneously and streamline processes in order to improve efficiencies The requirements for this role are as follows: - Ph.D. in a science related field - Minimum of 10 years of operational management experience in medical device organizations - Experience working closely with Board Members and Executive Committee - Strong understanding of scientific operations and extensive project management experience in the medical device field - Ability to manage teams effectively and manage multiple projects simultaneously - Strong technical background in the sciences]]>

<![CDATA[Job Responsibilities: The Research Associate will serve as Assistant Project Manager for multiple NIH-funded research studies as well as mental health outcomes tracking projects for state governments and organizations. The Research Associate will work closely with the Chief Operating Officer and Project Manager, as well as with a team of researchers and software programmers. Primary responsibilities will include creation and modification of IRB applications for research studies, preparation and maintenance of documents for Research Assistant training and assurance of research protocol adherence, long-distance management of Research Assistants in the field, preparation and maintenance of documents for state outcomes tracking project implementation, and providing support for clinicians and staff accessing state outcomes tracking websites and administering surveys to mental health clients. Additional responsibilities will include assistance with the development of project specifications and testing plans, testing software developed for administering surveys, database development and maintenance, analyzing data, literature review, and assistance with writing federal research grants and manuscripts for submission to peer-reviewed journals. Qualifications: BA + at least 2-3 years experience with research project management or MA in Psychology or related field with at least 1 year of experience with research project management preferred. Qualified candidates will be organized, very detail-oriented, and will work well independently as well as with a team. Previous experience managing social science research projects is required. Applications containing research experience solely within the basic sciences (e.g., Bio & Chem) will not be considered. Employment Terms: At least 0.75 FTE, full-time preferred. Salary commensurate with experience and qualifications. Company: TeleSage, Inc. is a privately owned, for-profit company located on Franklin Street in downtown Chapel Hill. Founded by Benjamin Brodey, MD, MPH, a graduate of MIT and Harvard Medical School. TeleSage has pioneered the development and application of automated survey administration and clinical reporting technologies for mental health and substance abuse treatment and clinical research. Interested applicants should email a cover letter and resume/CV to ra@telesage.com. Please describe your project management experience very clearly in your cover letter. Please title the email �Research Associate Position�. ]]>

<![CDATA[We are a local company looking for a scientist who can work independently to develop a wide range of immunoassays for our in-vitro diagnostic platform. RESPONSIBILITIES: � Manage all aspects of the assay development including activities such as: protocol and reagent optimization, validation and standardization for in-vitro diagnostic tests using company�s patented platform. � Implement and follow all cGMP and Standard Operating Procedures. � Ensure all product planning and other documentation requirements are met. � Work as an effective team member with others to identify and accomplish company objectives. QUALIFICATIONS: � Demonstrated assay development success in a related industry such as protein and DNA/RNA-based assays required. � Preferred a MS or PhD degree. Candidates with a BS and strong relevant experience will be considered. � Experience in medical device manufacturing and FDA regulations desired. � Must have demonstrated ability to work independently and exercise sound judgment and problem solving skills. ]]>

<![CDATA[Small research company seeks a mycologist. Duties to include maintaining culture collection, isolating fungi from natural substrates, conducting taxonomy, developing culture conditions to support metabolite production, maintaining database, etc. Candidates should have a masters degree from a recognized mycology department together with extensive bench level mycology in an industrial setting, and preferably some understanding of biochemistry and chemistry (please note this is not a molecular biology opportunity). ]]>

<![CDATA[Principal Research Associate-21390 Job Responsibilities/Department Description: The selected candidate will work as part of a fast-paced team in a GLP setting to be responsible for development, optimization and validation of immunoassays for assessment of immunogenicity in human serum samples. This position includes conducting validation studies, writing validation reports, and delivering oral presentations. The selected candidate must be able to work with minimal supervision and be able to handle multiple projects at a time. He or she must be able to independently define and implement a series of experiments to approach problems as well as independently analyze, evaluate, and organize generated data. Effective oral and written communication skills are necessary Basic Qualifications: BS degree in Chemistry, Biology, or Biochemistry with 9 years of industrial experience or MS degree with 7 years of industrial experience is required. Experience in immunoassay development, particularly ELISA, is also required. Preferred Qualifications: Experience with GLP and FDA guidelines. Experience with SoftMax and Prism is preferred along with some familiarity with statistics. Job: Research And Development Primary Location: United States-Massachusetts-Framingham Shift: Day Job Job Type: Regular Employee Status: Regular Apply Link: <a href="http://bioemployment.jobamatic.com/a/jbb/job-details/195339" rel="nofollow">http://bioemployment.jobamatic.com/a/jbb/job-details/195339</a> ]]>

<![CDATA[Process Development Engineer in Wilson, NC Must have CIP/SIP and process development experience from a sterile environment. (would consider solid dosage) Must be well versed in pharmaceutical/biotech processes from a hands on perspective Will be involved in FAT's, Start Ups, and Commissioning Must know HMI's, and Allen Bradley controls Duration is 6-9 months Start Date: ASAP ]]>

<![CDATA[Utility/Systems Validation Engineer Wilson, NC will be supporting existing project management team in the following: -Writing and executing commissioning and validation protocols (BAS, HVAC, other building utilities) -Verifying vendor testing of probes and sensors -Technical drawing verification and walkdowns applicable to building utilities Must have 5-10 years of experience in Pharmaceutical or Biotech environments (Biotech sterile preferred) Experience with HMI's BS degree in associated fields of study Primary skill set is validation. BAS (Building Automation Systems)experience is a plus. Experience with Allen Bradley is a big bonus. 6-18 Month contract with possible extension ]]>

<![CDATA[Commissioning Engineers will be responsible for leveraging integration, commissioning, all associated documentation, and validation for Delta V systems in a biotech environment. BSEE or engineering degree required and 3-5 years of experience(biotech and vaccine industries highly preferred but would consider pharmaceutical environments) Must have experience with generating code for Delta V systems and existing code review and associated documentation. Candidates local or commutable to RTP are STRONGLY preferred ]]>

<![CDATA[Applications are invited for a Temporary Research Technician position at the Neuro Image Analysis Laboratory, University of North Carolina at Chapel Hill in the area of Biomedical Image Analysis, focusing on MRI in rodent and primate studies. The position entails segmentation and tractography in regard to brain studies of rodents and primates, using diffusion tensor imaging and structural MRI. The primary duties will include collecting, processing, analyzing, and reporting medical image data connected with those studies. The candidate must be able to function well in a multidisciplinary team of researchers of different departments. The candidate�s responsibilities will be divided into medical image analysis, organization of animal imaging study data and creation of atlas delineations and manual segmentations of individual subjects for validation purposes as well as tractography. The Support Technician will be responsible for the processing of medical imaging data, both structural and diffusion tensor images (DTI), according to the current study protocols. The candidate must have a minimum of a BS degree in biology, biomedical engineering or related field and have prior experience in a research laboratory setting handling MRI and DTI. The candidate must also have prior experience with UNIX, perl, Matlab. The successful candidate will possess a positive �can do� attitude and strong computer skills with excellent attention to detail. The candidate must possess excellent organizational skills, attention to the detail, and awareness of the high value of accuracy in imaging studies where errors with data may have a significant negative impact. The candidate will regularly inform the research group about study progress and the status of analysis and projects. The Neuro Image Analysis Laboratory provides a unique interdisciplinary research environment incorporating collaborations with top-of-the-field researchers in Computer Science, Mathematics, Statistics, Radiology, Psychiatry, Pediatrics, Neurology and Cell-Biology. The candidate will benefit from mentorship of a diverse research team and will be exposed to cutting-edge technology. We are looking for an applicant with a strong background in biology. This is a temporary, full-time position, open immediately and the salary compensation is competitive. For consideration, please submit your application preferably in one single PDF document including cover letter, a full CV and the names and email addresses of three references to ipek at cs.unc.edu with subject line �Temporary research technician position: (your name)�. For more information please email Ipek Oguz (ipek at cs.unc.edu). EOE.]]>

<![CDATA[My name is Ana Giraldo and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Lab Tech for a prominent client of ours. This position is located in Durham, NC. Details for the positions are as follows; Job Description: Our client is looking for a Lab Tech who�s familiar with carrying out various biological or chemical research activities that involve routine test procedures to support product development or market support. These activities range from simple processes - general lab maintenance and record keeping to the more complex processes: planting germination and efficacy tests, setting up and conducting dust-abrasion studies. If you are interested in hearing more about the position please respond by sending your resume in WORD format to me at anag@thefountaingroup.com ]]>

<![CDATA[You can see it. New projects. New faces. A company that recognizes and values your contributions. Where your work challenges you and keeps you interested every day. And it provides compensation worthy of your expertise and hard work. If that looks good to you, you�ll want to know more about this opportunity from Manpower Professional. You�re precision-oriented, intuitive and a stickler for doing it right. You have a solid working knowledge of biological research and scientific study. You�re a critical thinker who is adept at using logic and reasoning to identify the strengths and weaknesses of alternative solutions. You understand the value of working as a team, yet you function strongly on your own. If this describes you, you�ll want to learn more about this opportunity from Manpower Professional. In this Lab Assistant position, you'll have the opportunity to: � Perform residue analysis for plant, animal and water matrices. � Wet chemistry analysis and sample organization. � Accurately record the results of technical experiments according to SOP's, GMP and FDA regulations � Maintain laboratory equipment Are you interested? The ideal Lab Assistant candidate will possess: � BS degree in CHEMISTRY � 1 year of experience with wet chemistry, GC/MS, LC/MS, HPLC. � Proficiency in MS Word and Excel � Must be a team player with excellent verbal and written communication skills You can see it. More challenging work. A more interesting work environment. The opportunity to use your finely honed skills to make a real difference. And to collect pay that reflects your talent and expertise. If this is what you see for yourself, you need to talk to Manpower Professional. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. We've got the right opportunity. Tell us why you're the right person! Apply today. ]]>

<![CDATA[Associate/Senior Associate Scientist: This person will provide protein identification, detection and assay support to the group. He/she should be able to work within a team with excellent organizational skill. Work will involve planning and executing laboratory based workpackages to express and purify recombinant expressed proteins, develop platforms to screen antibodies, develop and perform immunological and biochemical assays for proteins.The successful candidate must have proven hands on experience in the following techniques: protein isolation and purification, protein expression with and without tag, protein estimation, and immunological analysis including ELISA and Western blot, and enzyme assays. Experience in high throughput assay will be an asset. Knowledge on how to set up databases based on laboratory generated data is desired. He/she must have other computer skills needed for efficient day-to-day laboratory work. Strong background in plant molecular biology, biochemistry and immunological methods is required. The group is a service function. Successful candidate should be able to deliver completed task in a timely manner. The data generated by this scientist will be used in providing a finished work package to its customers. Report writing, presentation of his/her work and generating new ideas that will help BPS traits will be required of this scientist. Required Qualifications: MS with 3 years or BS with 7 years of experience in industry setting with major in Biochemistry or PhD with one year of experience in the area of protein research including but not limited to protein expression and purification, immunological assay development. Note: The Greer Group, Inc. will never ask you to submit your personal information or fill out a credit check application through Craigslist. If you are asked to do this in response to an ad on this site, please report this to Craigslist.com. ]]>

<![CDATA[Laboratory Assistant / MLT needed part-time to provide technical support for the operation of the Ridge Diagnostics (www.ridgedx.com) CLIA laboratory in Research Triangle Park, NC. The Lab Assistant in this small lab is responsible for assisting in the analysis of human serum samples for select biomarkers by immunoassay. The work will include routine maintenance and quality control on specified equipment, following written procedures. Activities will also include regulatory compliance (training, lab inspections, data integrity, QA/QC), sample management, sample testing, and inventory management under the guidance of the laboratory directors. This job will require direct laboratory work, with associated documentation and lab support functions including document filing, data entry, and faxing. The end product of this position is the generation of patient test results in compliance with all state and federal requirements for clinical laboratories (CLIA). Qualifications: At least an Associates degree in the laboratory science area. Valid registration as a Medical Laboratory Technician or equivalent experience. The candidate must meet the requirements in CLIA regulation Subpart M Sec.493.1489 for a high complexity testing lab. Excellent communication skills�written and verbal. Experience Requirements: At least 1 year laboratory experience, preferably in the performance of immunoassays, and preferably in a regulated (CxP, CLIA) laboratory. Skilled user of Microsoft Word, Excel, Powerpoint, and various web browsers. Licensure/Certification Requirements: None required, but MLT certification preferred. Hours of Work: by arrangement, 15 hrs/week (during 9am-5pm, Monday � Friday). This is a contract position. Please respond with resume and statement of interest.]]>

<![CDATA[Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. POSITION SUMMARY: PDM is the single point of contact in GCDS for the CPM. PDM is accountable for all data management activities. Assists in the development and implementation of new standards. Ensures data management project plan details are consistent with program level plans and milestones. Mitigates/arbitrates technical and process issues between outsourced partners. Ensures that the data management plan and cleaning strategy are consistent across the program. Serves as point of contact for internal and external audits. Ensures data flow across the program is within projected timelines. Ensures consistency in review and quality of safety data across the program. Reviews data quality audit outputs to identify trends across the program to ensure quality data. Reviews metrics and monitor performance against targets. Apply lessons learned to continuous improvement of data management practices within a program. PRIMARY JOB FUNCTIONS: �Focuses on quality of deliverables as well as the oversight of the DM activities at the program level (and protocol level where necessary) �Ongoing review of those items included in the Oversight plan �Support and guidance to LDM through ongoing activities �UIMS requests at early design stage (prior to LDM assigned) �Issues escalation from LDM (such as the team members not providing input in set timeline eg CRF review/comments) �Works directly with the CPM to ensure they have the support needed in their day to day interactions with the FSP for DM activities �Ensures the CPM is getting feedback from the LDM �Ensures the team is getting their outputs (clinical review listings etc) on a regular basis �Acts as the Single POC for all GCDS services at the Program level �Acts as the face of GCDS for their program or TA �Ensures consistency and quality of the data management activities across the TA/ program �Reviews use of TA standards across a program to ensure consistency �Trains and follows sponsor�s Standard Operating Procedures as applicable EDUCATION/SKILL/EXPERIENCE REQUIREMENTS: �Bachelor�s or equivalent degree preferred �Must have a minimum of 5 years of data management experience �Prior project management experience preferred �Experience working on multiple projects simultaneously �Experience with Oracle Clinical preferred For Immediate Consideration contact Kaitlin O'Mara at kaitlin.omara@premier-research.com or 617-237-1139]]>

<![CDATA[ImmunoAssay Specialist position available for immediate hire Advanced Liquid Logic Inc. (www.liquid-logic.com) is a well-funded early-stage company that develops microfluidic lab-on-a-chip devices for a diverse range of applications including clinical diagnostics, drug discovery, environmental monitoring and research instrumentation. Advanced Liquid Logic is commercializing �digital microfluidics� � a lab-on-a-chip technology in which nanoliter-sized droplets are programmably manipulated using electrical fields. Digital microfluidics is an emerging and highly interdisciplinary field at the intersection of engineering, biochemistry, clinical diagnostics, physics and materials science. DUTIES AND RESPONSIBILITIES: � Conduct research and development of diagnostic immunoassays on microfluidic devices � Using immunoconjugation methods, develop a �homebrew� magnetic bead-based fluorescence or chemiluminescence immunoassay protocol into a kit for use in droplet-based microfluidics � Work with engineers and technicians to translate bench-format assays to microfluidic format � Assist with the transition of research results to useful and manufacturable products � Maintain impeccable lab note books that document experimental setup and results; assist with developing and filing intellectual property; and assist with writing of grant proposals QUALIFICATIONS/CHARACTERISTICS: � Ability to work in a highly interdisciplinary environment along-side engineers, biochemists, and technicians; work under minimal supervision � Strong background in diagnostic immunology and magnetic bead-based separation methods � High integrity, insightful, industrious, team player, highly intelligent and most importantly, passionate about their work � Excellent verbal and written communications skills; strong analytical and computer skills for design of experiments and data analysis EDUCATION AND EXPERIENCE REQUIRED: � PhD in Biochemistry or a relevant discipline � Must have at least 3 years of diagnostic industry experience in the development of immunoassays, preferably FDA 510(k)-approved immunoassay product; will not consider academic or other industry experience � Experience in immunoassay development and reagent storage for disposable Cartridge-based products for HIV, a plus ]]>

<![CDATA[My client is looking for a Director/Sr. Director of Clinical Development. Must havea MD, PHD, or a PharmD. Must have clinical trials experience in either CNS, Neurology, or Pain Must have Phase III and Phase IV experience ]]>

<![CDATA[Serve as Principle investigator for bioanalytical studies. Performs quantitation of drugs in animal and human biomatrices using HPLC, automation, and LC-MS/MS. Develop and validate new LC-MS/MS methods for the quantification of drugs and their metabolites in biological samples. Write SOPs, validation, and bioanalytical reports. Perform calibration and maintenance of laboratory instrumentations. Serve as system administrator for laboratory instrumentations ► Act as Principle Investigator for bioanalytical studies. ► Manage sample inventory and storage. ► Develop and validate new LC-MS/MS methods. ► Analyze samples. ► Prepare documents for quality control and quality assurance reviews. ► Prepare and update SOPs to support regulatory environment. ► Prepare validation and bioanalytical reports. ► Perform routine maintenance of laboratory instruments. ► Serve as system administrator for laboratory instrumentations. ► Identify and maintain laboratory supplies. B. S. or higher degree in Analytical Chemistry or related discipline with 5-7 years of Industrial Bioanalytical experience. A solid background in Quantitative Bioanalysis in biological matrices using LC-MS/MS. ]]>

<![CDATA[ARE YOU CONSIDERING CHEEK AUGMENTATION? Aesthetic Solutions, PA is currently conducting a research study for men and women who have lost volume in their mid-face (cheeks). If you are between 35 and 65 years old and in good health, you may be eligible to participate in this study of investigational injectable filler for cheek augmentation. If you have received Botox�, Dysport�, or any injectable fillers within the past 12 months, you cannot participate. If you have had any facial plastic surgery at any time, you may not participate. Qualified participants will be compensated. For more information, please contact Naja Hines, Clinical Study Coordinator 919-403-6200, ext.120 or email nhines@aesthetic-solutions.com ]]>

<![CDATA[The Cytonet Group is active in the field of medical biotechnology. It develops, produces and markets new, cell-based, medicinal products. Cytonet partners include internationally leading university hospitals. Their basic research is carried over into internal procedural approaches and promising technologies with the aim of developing pioneering products as a result. Cytonet LLC specializes in the manufacturing of primary liver cells for cell therapy applications in the US and Europe within the field of cellular and biological therapeutics, and is seeking a Production Associate/Inventory Specialist OBJECTIVE The Production Associate/Inventory Specialist will support materials management operations to ensure that raw materials and critical components are ordered and received to specification, conform to government standards and satisfy GMP regulations, and that suppliers are properly assessed and qualified. In addition, in order to provide a quality cellular product, all necessary tasks must be performed cGMP guidelines. ESSENTIAL DUTIES/RESPONSIBILITIES 1. Ability to perform tasks independently, in a team environment. 2. Must be familiar with working in a clean room environment, gowning procedures, standard laboratory practices, and cGMP guidelines. 3. Follow all written SOPs and protocols that pertain to the scope of the position. These include, but are not limited to, the isolation and cryo-preservation of cell products for clinical use as well as completing supplier assessments and audits. 4. Perform all tasks as stated in SOPs associated with the manufacturing of cellular products. 5. Must be familiar with all equipment and associated protocols utilized by the manufacturing facility. 6. Maintain detailed records accurately, and concurrently with procedures. This includes but is not limited to batch production records. 7. Assist with incoming goods inspection/quarantine/release according to SOPs and specifications. JOB REQUIREMENTS 1. Flexible hours � the use of human tissue requires a 24/365 schedule 2. Some weekends and holidays are mandatory 3. Ability to work an �on-call� schedule 4. Some travel may be required; less than 25% QUALIFICATIONS � Bachelor�s degree in a scientific discipline or Associate�s degree with 2+ years experience � At least one year experience with GMP and performing environmental monitoring and personnel monitoring. Writing and revising standard operating procedures is preferred. � At least one year experience with material procurement, including supplier evaluations. Auditing experience is a plus. � Ability to read, understand, and follow standard operating procedures. � Experience with Microsoft Word, Excel, and Outlook. ENVIRONMENTAL (Please check all that apply and add additional information as required) PHYSICAL On the job the employee must: ( x ) Sit ( x ) Stand ( x ) Walk ( x ) Push/Pull ( x ) Kneel ( x ) Handle objects (manual dexterity) ( x ) Reach above shoulder level ( x ) Use fine finger movements ( x ) Other bend at the waist Must carry/lift loads of ( ) Light (up to 25lbs) ( x ) Moderate (25-50lbs.) ( ) Heavy (over 50lbs.) MENTAL On the job the employee must be able to: ( x ) Read/comprehend ( x ) Write ( x )Perform calculation ( x ) Communicate orally ( x ) Reason and analyze ( ) Other _____________ ENVIRONMENTAL On the job the employee: ( ) Is exposed to excessive noise ( ) Is exposed to marked changes in temperature and/or humidity ( x ) Is exposed to dust, fumes, gases, radiation, microwave (underline) ( x ) Works in confined quarters ( x ) Other works in a �controlled� environment EQUIPMENT � Environmental Monitoring Equipment: BioMerieux air samplers, Met-One Laser Particle Counter � Biological Safety Cabinet � Centrifuges � -20C and �80C freezers � 2C to 8C Refrigerators � Hematron heat sealer � Terumo Sterile Connecting Device ]]>

<![CDATA[The Greer Group, Inc. is recruiting for a large biotech company in the RTP area. Responsibilities: Residue analysis for plant/soil/animal and water matrices with established methodologies; and e-fate metabolism studies. Education /Experience: 1-2 years experience with B.S. in chemistry Equipment skills: Wet Chemistry, GC/MS, LC/MS/MS, HPLC; LSC Radiochemistry. Temporary position, Monday through Friday, 8-5, $14 per hour. Candidates must have a clean background and excellent professional references. Note: The Greer Group, Inc. will never ask you to submit your personal information or fill out a credit check application through Craigslist. If you are asked to do this in response to an ad on this site, please report this to Craigslist.com. ]]>

<![CDATA[THE FOUNTAIN GROUP IS A PROFESSIONAL SERVICE COMPANY AND WE HAVE AN IMMEDIATE CONTRACT JOB OPENING WITH ONE OF OUR CLIENTS FOR A LAB ASSISTANT Job Description: � Residue analysis for plant/soil/animal and water matrices with established methodologies; and e-fate metabolism studies Equipment skills: desire skills: wet chemistry, GC/MS, LC/MS/MS, HPLC; LSC radiochemistry Required Qualifications: � Education / experience desired: new graduate or 1-2 years experience with bachelor degree in chemistry ]]>

<![CDATA[Our client in RTP, NC, seeks a Research Pharmacologist/Bench Scientist for a long term contract position. The selected candidate would work in the Department of Pharmacology and Toxicology focused on molecular pharmacology and cell-based assay development. This department's work is currently focused on generating stable cell lines expressing protein targets of interest to treat drug addiction and CNS disorders. They develop and validate new assays and then run the assays to evaluate novel compounds. The ideal candidate will have a strong desire to use data interpretation skills. Job Responsibilities: � Generate stable cell lines expressing targets of interest � Create expression and reporter plasmids using standard subcloning and PCR techniques � Perform various cell-based assays � Evaluate interim results in generation of plasmids and cell lines, troubleshoot processes. � Support experimental design including appropriate controls � Assist colleagues in experimental design and troubleshooting � Learn and apply additional techniques as needed Position/Educational Requirements: � BS/MS degree � Sterile cell culture and molecular biology experience is required � Strong data interpretation � Significant experimental design and troubleshooting skills are required. ]]>

<![CDATA[This person will provide protein identification, detection and assay support to the group. He/she should be able to work within a team with excellent organizational skills. Work will involve planning and executing laboratory based workpackages to express and purify recombinant expressed proteins, develop platforms to screen antibodies, develop and perform immunological and biochemical assays for proteins. The successful candidate must have proven hands on experience in the following techniques: protein isolation and purification, protein expression with and without tag, protein estimation, and immunological analysis including ELISA and Western blot, and enzyme assays. Experience in high throughput assay will be an asset. Knowledge on how to set up databases based on laboratory generated data is desired. He/she must have other computer skills needed for efficient day-to-day laboratory work. Strong background in plant molecular biology, biochemistry and immunological methods is required. The group is a service function. Successful candidate should be able to deliver completed task in a timely manner. The data generated by this scientist will be used in providing a finished work package to its customers. Report writing, presentation of his/her work and generating new ideas that will help BPS traits will be required of this scientist. Required qualification: MS with 3 years or BS with 7 years of experience in industry setting with major in Biochemistry or PhD with one year of experience in the area of protein research including but not limited to protein expression and purification, immunological assay development. This is an 8 month+ contract assignment and there are two openings. Please send a Word formatted resume with contact information if you are interested and feel you are qualified. ]]>

<![CDATA[Medical device V&V engineer wanted for Cary consulting firm. Mid to senior level. Some local assignemnts but must be able to travel extensively. Understanding regulatory requirements for devices, Premarket Notification 510(k) and Premarket Approval process a must. Must be experienced with QSR, design controls, V & V process, master device records and submital requirements for instruments and reagents. Send resume to charles@pharma-sys.com. ]]>

<![CDATA[Validation engineer wanted for Cary consulting firm. Mid to senior level. Some local assignemnts but must be able to travel extensively. Automation experience a plus. Send resume to charles@pharma-sys.com. ]]>

<![CDATA[Hello, My name is Jason Babbitt. I represent The Fountain Group, a National staffing firm. We have a Contract opportunity with a prominent client for an Associate Scientist in RTP, NC. This person will provide protein identification, detection and assay support to the group. He/she should be able to work within a team with excellent organizational skill. Work will involve planning and executing laboratory based work packages to express and purify recombinant expressed proteins, develop platforms to screen antibodies, develop and perform immunological and biochemical assays for proteins. The successful candidate must have proven hands on experience in the following techniques: protein isolation and purification, protein expression with and without tag, protein estimation, and immunological analysis including ELISA and Western blot, and enzyme assays. Experience in high throughput assay will be an asset. Knowledge on how to set up databases based on laboratory generated data is desired. He/she must have other computer skills needed for efficient day-to-day laboratory work. Strong background in plant molecular biology, biochemistry and immunological methods is required. Required qualification: MS with 3 years or BS with 7 years of experience in industry setting with major in Biochemistry or PhD with one year of experience in the area of protein research including but not limited to protein expression and purification, immunological assay development For immediate consideration, please forward a current copy of your Word formatted resume to jason@thefountaingroup.com. ***Due to the volume of responses received, only qualified candidates will be contacted but your resume will be filed for future openings***]]>

<![CDATA[8+ month contract position This person will provide protein identification, detection and assay support to the group. He/she should be able to work within a team with excellent organizational skill. Work will involve planning and executing laboratory based work packages to express and purify recombinant expressed proteins, develop platforms to screen antibodies, develop and perform immunological and biochemical assays for proteins. The successful candidate must have proven hands on experience in the following techniques: protein isolation and purification, protein expression with and without tag, protein estimation, and immunological analysis including ELISA and Western blot, and enzyme assays. Experience in high throughput assay will be an asset. Knowledge on how to set up databases based on laboratory generated data is desired. He/she must have other computer skills needed for efficient day-to-day laboratory work. Strong background in plant molecular biology, biochemistry and immunological methods is required. The group is a service function. Successful candidate should be able to deliver completed task in a timely manner. The data generated by this scientist will be used in providing a finished work package to its customers. Report writing, presentation of his/her work and generating new ideas that will help BPS traits will be required of this scientist. Required qualification: MS with 3 years or BS with 7 years of experience in industry setting with major in Biochemistry or PhD with one year of experience in the area of protein research including but not limited to protein expression and purification, immunological assay development. If interested, please send Word formatted resume.]]>

<![CDATA[Pioneer a brighter future When you join Novozymes, you'll lead the way to create a brighter future. To realize your full potential, you'll be supported by your colleagues who share the same goals and ambitions as you. Be part of a team that values your expertise and where you can make a difference. Associate Scientist Are you passionate about detergents? If so, join our Customer Solutions team to have the unique opportunity to partner with customers in the detergent industry using biotechnology to challenge traditional thinking in order to find sustainable solutions. You will guide them in optimizing production and take current applications to the next level, while collaborating with other Zymers on cross functional and international teams. You'll join forces to think about what's next, and work to make it a reality today.<img src="http://www.jobtarget.com/c/includes/jvimg.cfm?site=7&job=6515684"> Here's what it takes: <ul> <li>BS degree minimum preferred </li> <li>Experience from working in the detergent industry or detergent ingredient industry is required. </li> <li>Experience with product support, detergents formulation and development using raw materials highly preferred.</li> <li>Laboratory experience with enzymes for detergents is highly preferred.</li> <li>Demonstrated great communication, interpersonal, teamwork and customer service skills.</li> <li>Ability to travel a minimum of 40-50%, including international travel.</li> </ul> Step up for the challenge and apply online at <a href="http://www.novozymes.com/careers" rel="nofollow">novozymes.com/careers</a>. Novozymes is an Equal Opportunity/Affirmative Action Employer M/F/D/V. Rethink tomorrow Novozymes is the world leader in bio-innovation. We create tomorrow's solutions by applying technology to nature, to the benefit of both our customers' bottom line and the planet. Novozymes serves a broad array of industries using enzymes, microorganisms, biopolymers, and biopharmaceutical ingredients. With over 700 products in 130 countries, Novozymes' bio-innovations improve industrial performance and safeguard the world's resources because they represent superior and sustainable solutions for tomorrow's ever-changing marketplace. <center><a href="http://www.apply-for-job.net/c/jobclick.cfm?site=7&job=6515684" rel="nofollow">Click Here to Apply</a></center> ]]>

<![CDATA[Company Overview Millennium Laboratory strives and achieves Laboratory Excellence. Headquartered in Raleigh, NC, Millennium is accredited by both COLA and CLIA. Medical Technologist Millennium Laboratory is actively seeking qualified candidates interested in working either Full-Time in Raleigh, North Carolina from 10 am -7 pm. This is a supervisor role . Job Requirements: Medical Technologist Requirements: � MT(ASCP) or equivalent required � Excellent communication and writing skills � 7+ years of experience Job Benefits: Position offers excellent benefits and competitive salary. Please send resume to Attn: HR , 3362 Six Forks Rd, Raleigh, NC 27609 or email: lisah@millenniumlaboratory.com www.millenniumlaboratory.com ]]>

<![CDATA[The Duke Genomic Analysis Facility within 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. Responsibilities include: � Develop and support next-generation sequencing platform � Employ multiple genotyping technologies in support of various biological and medical research programs � Perform routine laboratory management activities, including ordering supplies and maintaining inventories, preparing reagents, and managing instruments Requirements: Candidates should possess a bachelor's degree in biology, genetics, or related biological field with some experience in a research laboratory setting. 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 Microsoft Excel required, as is ability to become proficient in new software applications and databases.]]>

<![CDATA[Analytical Chemist within Pharmaceutical Industry: Contract Position, High Point, NC Kelly Scientific Resources is currently recruiting for an excellent contract opportunity in High Point, NC. This position will require development of formulations and manufacturing processes for research compounds intended for clinical studies in humans. This position is anticipated to last 3-6 months but could be extended based on increased work opportunities over the duration of the contract. Only local candidates will be considered. Essential Functions: - Prepare lab scale batches of the prototype formulations, tablets, capsules, solutions. - Set up prototype formulations on stability studies. - Perform stability testing at various intervals, such as HPLC Assay/impurities, dissolution and moisture testing. - Conduct preformulation studies to characterize the research compounds - Compile and review the analytical data and prepare study reports - Develop analytical methods for drug substances and drug products Requirements: - BS/MS degree in Chemistry or Pharmaceutical Science related fields - Prefer 1-2 years industrial experience in formulation development and analytical method development of solid dosage forms - Familiar with analytical testing equipment, HPLC, dissolution, moisture KF, UV spectrophotometer and training in GLPs and GMPs - Familiar with solid dosage processing equipment, tablet press, capsule filling, granulation, fluid bed. Please apply online at www.kellyscientific.com or send resume to 4531@kellyscientific.com for immediate consideration. 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. ]]>

<![CDATA[Greenhouse Technician Manpower Professional is looking for Greenhouse Technicians, to work with one of our clients in the Raleigh, NC area. In this position, you will have the opportunity to: � Perform work in support of botany and plant studies. � Gather field, greenhouse and laboratory data from a variety of sources such as instrument readings, field measurements, observations, and/or inspections. � Collect environmental data, identify plant species and measure individual plant characteristics. � Prepare technical reports, diagrams, charts, graphs and scientific tables in support of botany and plant research studies. The ideal Greenhouse Technician will possess the following qualifications: � BS degree in Biology, Plant Science, Horticulture or related field. � 1 year of experience working in a Greenhouse is required. � Hands-on experience with seeding, watering, thinning and spraying plants is required. � GMP experience preferred. Besides gaining valuable experience with some of the most reputable organizations in the market, you�ll gain access to Manpower Professional�s comprehensive benefits package. We offer all the advantages you would expect from an industry leader � including a competitive salary, comprehensive health benefits, paid time off, training and much more. Please forward a MS Word resume to amanda.thompson@na.manpower.com for consideration. ]]>

<![CDATA[Systems Development position available for immediate hire Advanced Liquid Logic Inc. (www.liquid-logic.com) is a well-funded early-stage company that develops microfluidic lab-on-a-chip devices for a diverse range of applications including medical diagnostics, drug discovery, environmental monitoring and research instrumentation. Advanced Liquid Logic is commercializing �digital microfluidics� � a lab-on-a-chip technology in which nanoliter-sized droplets are programmably manipulated using electrical fields. Digital microfluidics is an emerging and highly interdisciplinary field at the intersection of engineering, medical diagnostics and materials science. DUTIES AND RESPONSIBILITIES: 1. Responsible for overseeing the team developing a point-of-care (POC) in vitro diagnostic system based on digital microfluidic technology 2. Has overall responsibility for the development of project plans to meet company requirements and the successful execution of those plans. 3. Develops budget and resource requirements. Ensures that adequate resources are available to meet obligations 4. Responsible for the technical content of departmental activities. Provides input for the technical content of proposals and contracts 5. Ensures that all projects are undertaken in compliance with the quality system (ISO 13485 & FDA QSR) and the technical requirements 6. Responsible for hiring and training of staff members as required to meet project objectives 7. Work closely with R&D and Manufacturing teams to transition the research into product development QUALIFICATIONS/CHARACTERISTICS: � High integrity, insightful, passionate, industrious, and highly intelligent � Must be able to lead a multidisciplinary team including engineers and biologists � Must be able to provide technical leadership in the development of a POC in vitro diagnostic system � Self-motivated with personnel management skills, verbal and written communications skills, strong analytical abilities and problem solving skills EDUCATION AND EXPERIENCE REQUIRED: � At least 10 � 15 years experience of relevant experience in the development of in vitro diagnostics and/or portable analytical instruments � Management experience � BS or higher degree in Engineering or Scientific discipline ]]>

<![CDATA[Advanced Liquid Logic Inc. (www.liquid-logic.com ) is a well-funded early-stage company that develops microfluidic lab-on-a-chip devices for a diverse range of applications including medical diagnostics, drug discovery, environmental monitoring and research instrumentation. Advanced Liquid Logic is commercializing �digital microfluidics� � a lab-on-a-chip technology in which nanoliter-sized droplets are programmably manipulated using electrical fields. Digital microfluidics is an emerging and highly interdisciplinary field at the intersection of engineering, biology, medical diagnostics, physics and materials science. DUTIES AND RESPONSIBILITIES: � Support the research and development of microfluidic devices in life sciences applications including DNA sequencing, sample preparation and PCR � Optimize chemistries and protocols for translation to droplet-based microfluidic format, including especially pyrosequencing and genomic sample preparation protocols � Develop reagent quality testing methods and establish quality control measures for routine use and long-term storage of reagents � Work closely with engineers and technicians to translate bench-format assays to microfluidic format � Assist with the transition of research results to the development of products � Maintain impeccable lab notebooks documenting experimental methods and results; assist with developing and filing intellectual property; assist with writing of grant proposals and reports QUALIFICATIONS/CHARACTERISTICS: � Ability to work in a highly interdisciplinary environment along-side engineers, biochemists, and technicians; ability to work under minimal supervision � High integrity, insightful, industrious, team player, highly intelligent and most importantly, passionate about their work � Excellent verbal and written communications skills; strong analytical and computer skills for design of experiments and data analysis EDUCATION AND EXPERIENCE REQUIRED: � PhD in Biochemistry, Molecular Biology or relevant discipline � Strong background in nucleic acid biochemistry � Minimum of three years experience in an academic or industrial laboratory � Pyrosequencing, next generation DNA sequencing or microfluidics experience a plus ]]>

<![CDATA[This position is part of a multi-disciplinary team that is providing scientific and operational support for a large portfolio of NIH-sponsored clinical trials and observational studies in the area of dental and craniofacial disorders. The administrative assistant will provide a wide variety of secretarial and administrative support services for the team. Essential Duties and Responsibilities include the following. Other duties may be assigned. �Apply organizational skills to the management of projects, daily schedules, work priorities, multiple tasks and unexpected interruptions in an ever-changing environment. �Work independently on special, non-recurring and ongoing projects. �Communicate concisely and effectively with diverse clients and staff. �Work all office machinery, including computer, fax machine, phones, copiers and printers. �Arrange and receive deliveries. �Solve unexpected problems/situations for the office. �Keep meeting and teleconference calendars. �Arrange and sort overnight and daily mailings. �Coordinate meetings and conference calls. �Purchase supplies. �Take and draft minutes for meetings and conference calls. �Format documents for project staff. �Create templates for the office. �File, copy, and bind documents. �Create labels and binders for projects. The candidate must be a team-oriented professional with strong initiative and a positive attitude. Candidates must be highly organized with exceptional attention to detail, the ability to multi task, have strong written and oral communication skills, prioritization skills and be able to work under tight deadlines. The candidate must have excellent inter-personal skills and have good use of judgment and sensitivity. Candidates must have thorough knowledge of Windows application including Word, Excel, Outlook and PowerPoint. This is an entry level position. Bachelor's degree and 3+ years prior administrative experience required. Please apply online by submitting your resume and cover letter, along with salary requirements, to <a href="http://www.rhoworld.com/rho/career-center/opportunities" rel="nofollow">http://www.rhoworld.com/rho/career-center/opportunities</a> Rho is an EOE.]]>

<![CDATA[Company overview: Nanosyn is an integrated chemical and biological services contract research organization providing innovative solutions in the areas of chemical libraries synthesis, medicinal chemistry, high-throughput bioactivity profiling and assay development services. Job Description: The Process Engineer supports the operation of high-throughput screening facility by performing preventive and repair maintenance on micro-fluidics capillary electrophoresis, CLND-HPLC and liquid handling instruments. This position will work closely with other personnel to ensure that all equipment is maintained, calibrated, and verified for proper performance. This position will serve as the key point for technical expertise on the instrumentation and will also be heavily involved in continuous improvement and innovative projects to implement new methods related to analytical chemistry, enzymology and cell-based assays. Duties: -Perform preventive maintenance on a fleet of micro-fluidic electro-separation devices (such as Caliper � LabChip instruments), HPLC systems, liquid handling systems (such as Biomek � FX workstations). -Respond to breakdown repair requests and return equipment to working condition. -Calibrate and monitor the performance of the equipment. -Programming liquid handling instruments to perform serial dilutions, reformatting and replication operations. Qualifications: The successful candidate should meet the following minimum requirements: -Demonstrated expertise in maintaining and repairing laboratory equipment, ideally the high throughput electrophoresis, liquid handling and high performance liquid chromatography systems. -Has been intimately familiar with the concepts of: � Capillary electrophoresis � Liquid chromatography � Lasers and optics calibration and alignment Contact information: Please send you resume to: Sergei Romanov at: sromanov@nanosyn.com ]]>

<![CDATA[Position Description Provides medical leadership for the therapeutic area (Pain, Neuroscience, Hospital Acute Care) with strategic direction and oversight of medical planning and execution of key projects supporting the brands, significant involvement in life cycle management opportunities, and support of business development projects Essential Skills The essential duties of this position include but are not limited to: � Establishes Medical Development as a key support and operational function for the company; increases visibility of Medical Affairs internally and externally � Provides medical expertise/ input to commercial brand teams and product development teams; participates in life cycle management discussions and decisions � Provides business development support - medical reviews and/or due diligence � Collaborates effectively with R&D colleagues to create seamless transitions of products form Clinical Development to Medical Development � As MDL (Medical Development Leader) for in-line products - Responsible/accountable for medical team activities, deliverables and budgets for the brand and/or functional area � Leads the process of developing Medical plans fully aligned with brand strategies and resource allocation decisions including phase IIIb/IV trials, medical communication strategies -- abstracts, publications, support of MSL activities, medical education etc. � Oversees execution of medical plans, phase IV trials, and establishes appropriate metrics; reports on deliverables at least quarterly � Provides high level oversight of vendor management by the team � Identifies educational needs for the therapeutic area based upon unmet medical needs and assists in review and prioritization of educational grant requests � Assures appropriate identification and engagement of KOLs as advisors, investigators, etc. � Assists in development and implementation of a KOL management system/platform � Synthesizes customer insights and medical intelligence provided by the field teams for communication to the brand planning and product development teams � Assures collaboration with field medical leadership to develop high quality scientific materials for use by the MSLs; champions their review and approval as necessary � Collaborates effectively with all internal stakeholders � Provides direction, training and follow-up to ensure compliance with policies and SOPs; exhibits leadership by example � Coaches and mentors others, and promotes a culture of innovation, constructive challenge, team spirit and accountability Knowledge and Skills Necessary to Perform this Job: � Knowledge of Disease Area. � Strong leadership skills � Effective communication and presentation skills � Word, Powerpoint and Excel skills � Demonstrated proficiency in writing and development oversight of phase IIIb/IV clinical study synopses and protocols � Understanding of FDA regulations, OIG guidances, and Pharma Code of Conduct requirements The position requires: � Advanced degree in medical science (MD, PhD, or PharmD) � 3-5 years pharmaceutical experience in medical affairs, developing and executing medical plans including phase IIIb/IV trials and publications � Demonstrated ability to lead a matrix team, manage and resolve conflicts, and establish strong working relationships with other departments � Vendor management experience (eg. CROs or publication vendors) desirable � Ability to build credible scientific relationships with KOLs in the disease area Please send your resumes or contact information to Nick_Chlam@live.com]]>

<![CDATA[(2) Utility Systems Validation Engineers Durham, NC will be supporting existing project management team in the following: -Writing and executing commissioning and validation protocols (BAS, HVAC, other building utilities) -Verifying vendor testing of probes and sensors -Technical drawing verification and walkdowns applicable to building utilities Must have 2-5 years of experience in Pharmaceutical or Biotech environments (Biotech preferred) BS degree in associated fields of study Primary skill set is validation. BAS (Building Automation Systems)experience is a plus. Experience with Siemens is a big bonus. These would be support level resources working under our on-site PM. 6-18 Month contract with possible extension ]]>

<![CDATA[My client is a privately-held biotechnology company that is using proprietary technology to develop vaccines products. They are currently seeking a seasoned hands-on scientist with strong management skills and a record of achievement in vaccine development. In this technical leadership role you will: Lead effort to evaluate efficacy of vaccines in development and manage projects/resources to ensure timelines/milestones are met Contribute to the development of novel vaccines from early stage into clinical development and into manufacturing Effectively work with cross-functional internal teams as well as external collaborators Ability to spend majority of time on the bench as well as manage projects/mentors junior scientists Ability to collaborate with executive management and business development to evaluate new vaccine technologies Requirements: Ph.D. in a biological sciences related field 10+ years of vaccine industry experience Ability to manage a team of other scientists (up to 6 direct reports) A strong record of publications and recent presentations at related conferences Excellent communication and mentoring skills For immediate consideration - please forward your resume in Word format along with salary requirements.]]>

<![CDATA[A growing and progressive Raleigh company is seeking a COO level individual with the a solid career in the medical device industry. The qualified individual will posses experience in: - medical device field - managing multiple projects simultaneously - leading a group of scientists and researchers effectively in order to meet organizational objectives - experience in a C-level role and effectively working with CEO to create and execute strategic projects - creating new innovations that will have the organization's long term goals in mind The ideal candidate must possess all of the following requirements: - PhD in a science related field - Minimum of 10 years of management experience in the medical device industry - Experience working as a COO or General Manager in a small to medium sized organization - Able to handle many projects simultaneously - Strategic business experience in an operations environment - Strong technical skills - Ability to communicate effectively with all levels of management - Experience in the cardiology field, a plus]]>