Associate Director, Process Development, Cell Therapy
Core
Provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for late-stage cell therapy products from clinical development through commercialization.
Role type
Senior IC process development lead (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, AI tools for data analysis, technical writing, data analysis, risk assessment, root cause analysis, CAPA development, lifecycle management, regulatory submissions (BLA/MAA), DOE design, multivariate data analysis
Preferred skills
Commercial-stage cell therapy experience, biologics product experience, global regulatory requirements knowledge, process validation, post-approval changes
Technologies
AI-enabled tools, digital analytics, batch record systems, CMC documentation tools
Responsibilities
Lead late-stage process development projects; manage and develop a team of scientists and engineers; conduct batch record reviews and deviation assessments; 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
