Senior Director, Late Stage Cell Therapy Process Development

Role: Senior Director, Late-Stage Cell Therapy Process Development, leading the development of scalable, robust manufacturing processes for PSC-derived islet products targeting Type 1 diabetes. Responsibilities: oversee process development from research integration (bioreactors, automation) through technology transfer, process validation, and regulatory support (IND/BLA); author regulatory documentation; collaborate across multidisciplinary teams; mentor engineering staff; contribute to organizational strategy and innovation. Requirements: Ph.D. in Biochemical or Chemical Engineering or related field; 10+ years in cell therapy process development with 5+ years in late-stage, including GMP experience; hands-on expertise with perfusion and single-use bioreactor systems at various scales; knowledge of stem cell biology, GMP raw materials, and process analytical tech; experience supporting regulatory filings, tech transfer, and risk analysis; strong influencing, communication, and leadership skills. HighValue: cell therapy (PSC-derived islets), late-stage, GMP manufacturing, regulatory submissions, process validation, automation and bioreactor expertise, cross-functional collaboration. WorkSetup: onsite Cambridge, MA.