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Director, Product Quality Management
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Full-time
- The candidate will have previous experience leading and managing product quality for cell therapy programs in a phase-appropriate manner and will provide a proactive front-end approach to product quality.
- Working with QC, Analytical Development and CMC Regulatory, provide technical expertise and quality input into review and approval for overall product analytical strategy, method development, method transfer, qualification, and validation
- Bachelor’s degree in Virology, Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology
- Minimum 12-15 years’ pharmaceutical experience; preferred experience in cell therapy or biologics product development and licensure
- Experience in cell line development, production, and qualification of attenuated viral banks
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