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| Job Title: |
Director of Bioanalytical & Analytical Methods Development - Viral Vaccine Clinical Supplies |
| Job ID: | DBV-NC-031504 |
| Location: | Research Triangle Park, NC |
| Industry: | Pharmaceuticals |
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Description:
Come join the innovative team at this small, dynamic, growing company serving the pharmaceutical industry with new and novel technologies in the field of oncology and infectious diseases.
Direct, manage and participate in the development, qualification and validation of analytical and bioanalytical methods used for product characterization, process development and QC in-process and release tests for viral vaccine clinical supplies.
Develop methods to assist in process development activities. Manage vaccine substance and product stability testing in support of clinical lot production. Assure that testing is performed according to current regulatory guidelines. This position will coordinate activities across relevant functional areas and may handle other non-technical administrative duties on a limited basis.
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Develop and conduct robust bioanalytical and analytical methods to support in process and product characterization.
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Assemble vaccine characterization data and develop product specifications. Manage QC release testing and stability programs.
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Conceptualize, design, and apply new methodologies and provide for the transfer of methods to or from other laboratories.
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Actively liase with colleagues and customers to provide regular, high quality, concise and timely data and feedback / communication. Tutor, train, and advise colleagues in areas related to analytical sciences.
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Assure activities are conducted in accordance with corporate procedures, SOPs, GLPs and GMPs. Serve as a technical representative and/or technical lead on projects and coordinate project activities with other functions.
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Estimate resource requirements in order to determine cost estimates for projects included in proposals. Maintain a high level of scientific excellence by regularly attending national and regional technical meetings and presenting technical work whenever the opportunity arises.
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The position requires a Ph.D. in Virology, Biochemistry, Chemistry, Microbiology or related discipline plus at least eight years of biological/pharmaceutical development experience, preferably in an analytical development role.
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The successful candidate should be highly skilled in methods of viral vaccine analysis (plaque assays, cellular DNA/protein contaminants), recombinant DNA techniques (Southern, Western blots), standard immunochemical methods (ELISA, IFA), and FDA (CBER) requirements for vaccine release (adventitious agent testing, CFR methods) and analytical skills.
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Advanced knowledge for the development, qualification and validation of bioanalytical methods used in vaccine development.
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Solid knowledge of GLP, and GMP requirements for vaccine development.
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Possess a strong fundamental and working knowledge of pre-clinical and biological/ pharmaceutical sciences, and knowledge of instrument analysis. Ability to develop, implement and troubleshoot analytical methods.
- Have strong verbal, written communication and organizational skills.
Your Career Partner:
Management Recruiters of Plant City is dedicated to the nationwide search and placement of the highest quality Analytical Chemists, Pharmaceutical Scientists, Laboratory Managers and Directors. Our clients are leading- edge pharmaceutical manufacturers, contract laboratories, research organizations and biotech companies.
Our staff of career counselors is lead by a scientist who was the Director of Marketing & Applications for Hewlett-Packard's Chromatography/Mass Spectrometry Division. As a result of our technical expertise and ability to supply superior candidates, we have gained the respect and trust of our client base.
If you would like to be kept informed of nationwide opportunities that match your background, experience and career aspirations, please forward your resume to us in strictest confidence. We really can help you!
Compensation: $90,000 - 130,000 plus excellent benefits.
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| Contact: | David Zaring
Careers@PharmaceuticalChemist.com
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