Director, Validation

Role: Lead development and execution of the laboratory validation program supporting research, translational medicine, manufacturing sciences, and analytical development for autologous cell therapy products, including CAR T cell therapies. Responsibilities: establish validation strategies for equipment, computerized systems, and infrastructure aligned with FDA, EMA, ICH, and GxP standards; ensure inspection readiness; oversee vendor validation deliverables; and integrate validation within quality systems. Lead cross-functional collaboration with QA, R&D, IT, and external vendors; mentor validation teams; and support validation activities during laboratory expansion and technology transfers. Requirements: Bachelor's in Engineering, Life Sciences, or related; 12+ years in biotech/pharma with at least 5 years in validation leadership; supporting BLA/NDA submissions and FDA inspections desirable. Expertise in equipment qualification (IQ/OQ/PQ), CSV, risk-based validation, GAMP 5, 21 CFR parts 11/210/211, and data integrity principles essential. High-value specifics include experience with laboratory automation, flow cytometry, PCR, bioanalytical instrumentation, and knowledge of autologous cell therapy validation workflows. Work setup: Remote or hybrid; based in Philadelphia, PA.