Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations
Core
Senior technical leader for Cell Therapy manufacturing sites, responsible for process transfer, validation, commercial supply, and team leadership across a global network.
Role type
Senior Director, Site Manufacturing Science and Technology (Cell Therapy)
Builds
Cell therapy products for clinical and commercial supply
Domain
Biopharmaceuticals / Cell Therapy / Manufacturing Science and Technology
Required skills
Cell therapy manufacturing processes, GMP operations, process validation, commercial supply, team leadership, regulatory compliance (cGMP, ICH), change control, risk mitigation, technology transfer
Preferred skills
Experience in biologics, viral vectors, or vaccines, advanced degree in engineering/biology
Technologies
GMP systems, manufacturing equipment, CMC documentation
Responsibilities
Define and execute Site MSAT function strategy; build and mentor high-performing MSAT teams; lead late-stage and commercial process execution; represent MSAT in technology transfer and process validation; lead clinical manufacture and PPQ readiness; implement Proactive Process Analysis (PPA) and Continued Process Verification (CPV); identify and implement process improvements for robustness and cost; serve as accountable leader for regulatory submissions (IND, BLA, MAA); lead site preparedness for health authority inspections.
Seniority
Senior Director, strategic leadership with hands-on technical oversight