Directs the coordination of activities related to the testing, release, and stability testing of biological products for investigational use in human clinical trials. This position is also responsible for oversight of biological assay development, including but not limited to cell-based, flow cytometry, PCR, ELISA, and coordinating outside testing activities (adventitious agent testing, DNA sequencing, etc). This position requires an in-depth knowledge in the Biological Sciences (virology, cellular biology, biochemistry and microbiology), Analytical Chemistry and Biochemistry, and current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) regulations. The Director of Quality Control will be expected to maintain an extensive knowledge and expertise in Federal Regulations and International Conference on Harmonization (ICH) guidelines pertaining to the testing and release of biological products for clinical trials and the appropriate scientific expertise to evaluate product quality. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment, within generally defined practices and policies, in selecting methods and techniques for obtaining solutions. This position is subject to extended hours and callback as needed. Requires an individual with proven technical skills and management skills in the analysis and testing of biologics manufactured under cGMP and current Good Tissue Practice (cGTP), production and scale-up in one or more of the following areas.
Master's degree in a relevant area of biological science required. Ph.D. preferred
Master's degree with ten (10) years' experience in a relevant area of biological science/engineering with some laboratory management experience required. OR Ph.D. with seven (7) years' experience in a relevant area of biological science/engineering with some laboratory management experience required. Work in a FDA regulated production environment preferred
None LICENSURE, REGISTRATION AND/OR CERTIFICATION REQUIRED BY CHILDREN'S GMP, LLC ONLY: None
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