Associate Director, Process Development, Cell Therapy
Core
Provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products from clinical development through commercialization.
Role type
Senior IC process development leader (cell therapy)
Builds
Robust, compliant, and scalable manufacturing processes for cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Cell therapy process development, GMP operations, late-stage development, PPQ, risk assessment, data analysis, technical writing, AI-enabled tools, digital analytics, root cause analysis, CAPA development, lifecycle management, regulatory submissions (BLA/MAA)
Preferred skills
Commercial-stage cell therapy or biologics experience, process validation, post-approval changes, global regulatory requirements
Technologies
AI tools, digital analytics platforms
Responsibilities
Lead late-stage process development projects; direct engineers/scientists in study design and report authoring; conduct batch record review and deviation assessment; support PPQ activities and technology transfer; lead lifecycle management and post-approval changes; serve as SME for manufacturing deviations and investigations; contribute to CMC documentation and regulatory submissions
Seniority
Senior, hands-on IC with team leadership