Associate Director, Process Development, Cell Therapy

Role: Associate Director, Late-Stage Cell Therapy Process Development, leading scientific and technical efforts for manufacturing process development, characterization, and transfer from clinical to commercial stages. Responsibilities: oversee late-stage process development projects, guide engineering teams in documentation, risk assessment, data analysis, batch review, and applying AI tools for process acceleration; manage lifecycle activities including process monitoring, improvements, and regulatory commitments; support PPQ activities and technology transfer; serve as SME for manufacturing deviations and investigations; contribute to regulatory documentation and submissions; collaborate cross-functionally with Manufacturing, Quality, Regulatory, and Analytical teams. Qualifications: Ph.D. in relevant sciences or equivalent experience (6+ years for Ph.D., 10+ for M.S., or 12+ for B.S.); expertise in cell therapy GMP process development, late-stage/ commercial readiness, and digital tools; strong technical writing and problem-solving skills. Preferred: experience with commercial cell therapy or biologics, process validation, post-approval changes, and global regulatory knowledge; proficiency in DOE and multivariate analysis. HighValue: cell therapy (modalities unspecified), late-stage/ commercial, process validation, PPQ, AI-enabled data analysis, cross-functional collaboration. WorkSetup: hybrid; salary range $138K–$207K, with incentives, benefits, and bonuses.