Director, Product Quality Leader

Role: Product Quality Leader overseeing Allogene's CAR T programs, including starting materials, viral vectors, and nucleic acids, with a focus on product design, characterization, and qualification in allogeneic cell therapy. Responsibilities: manage quality activities for clinical and commercial manufacturing at internal and contract sites; develop and oversee stability studies, specifications, method validations, and comparability assessments; support product transfer, process qualification, and regulatory documentation; ensure compliance with cGMP and FDA regulations; lead investigations into deviations and OOS results, and drive CAPA actions; represent Quality on CMC teams and support regulatory inspections. Requirements: Ph.D. in life sciences with 7-10+ years biotech experience, including biological drug development, process validation, and regulatory interactions; expertise in analytical/biological methods, stability programs, and statistical tools (e.g., JMP); proven leadership and experience managing GMP audits and inspections. HighValue: allogeneic CAR T therapies, cell-based modalities, early to late-stage clinical development, regulatory filings, and process validation. WorkSetup: based in Newark, CA.