Senior Director, Manufacturing Science and Technology, Cell Therapy Technical Operations
Core
Senior technical leader for end-to-end cell therapy manufacturing across a global network, overseeing processes from validation through commercialization and lifecycle management.
Role type
Senior Director, Manufacturing Science and Technology (Cell Therapy)
Builds
Cell therapy products for clinical and commercial supply
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Cell therapy manufacturing processes, GMP operations, process validation (PPQ), continued process verification (CPV), regulatory submission authoring (CMC), team leadership, risk mitigation, supply planning
Preferred skills
Advanced degree (M.S./Ph.D.), experience with biologics/viral vectors/vaccines, health authority inspection leadership
Technologies
cGMP, ICH guidelines, validation master plans, change control systems
Responsibilities
Define and execute global MSAT function strategy; build and mentor high-performing technical teams; develop technical standards for process validation and market approval; represent MSAT in technology transfer and process characterization; oversee PPQ readiness and execution; develop and implement Proactive Process Analysis (PPA) and Continued Process Verification (CPV) strategies; provide technical oversight from pivotal manufacturing readiness to post-approval; lead MSAT preparedness for health authority inspections; author and approve CMC sections for regulatory submissions (INDa, BLA, MAA).