Director, Product Quality Leader
$200,000–$230,000 year
HybridSouth San Francisco, California, United States
Job Summary
Oversee quality activities for Allogene's CAR T programs, including oversight of drug substance/drug product manufacturing internally or at contract manufacturing organizations for clinical and commercial use. Drive development of product specifications, stability studies, and comparability strategies while managing discrepancies, Out Of Specifications results, and CAPA implementation. Represent Quality on CMC teams to support product transitions from clinical to commercial stages, ensuring conformance to FDA and international regulatory requirements. Author and review technical registration documents, interact directly with auditors during inspections, and partner with Regulatory Affairs on submissions. This role supports the creation of an outstanding product design and qualification capability in the allogeneic cell therapy space, working out of the Newark, California office.
Required Qualifications
- Ph.D. degree in life Sciences
- minimum of 7-10 years of experience in the biotechnology
- Practical knowledge and solid understanding of biological drug development process from early development to product launch and support of commercial products
- Sound knowledge of cGMP and regulatory compliance (US and other international agencies)
- Proven track record of successfully managing PAI and/or GMP inspections
- Experience with analytical and biologicals methods development, optimization and validation, as well as stability programs
- Strong knowledge of statistics and working experience with statistical and trending software such as JMP
- Experience in managing and investigating deviations and CAPA implementation
- Experience in dealing with regulatory agencies supporting regulatory filings
- Experience with project management in a matrix organization
- Strong leadership ability, interpersonal, communication, and influencing skills
- Candidates must be authorized to work in the U.S.
Desired Qualifications
- Process validation experience is a plus
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