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 lifecycle management.
Role type
Senior Director, Site Manufacturing Science and Technology (MSAT)
Builds
Cell therapy products for clinical and commercial supply
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
Cell therapy process science, GMP operations, technology transfer, process validation, commercial supply planning, risk mitigation, regulatory compliance (cGMP, ICH), change control, lifecycle management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Define and execute site MSAT function strategy; build and mentor high-performing MSAT teams; lead late-stage and commercial process execution; represent site 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 senior accountable leader for regulatory submissions (IND, BLA, MAA); lead site preparedness for health authority inspections; partner with quality and regulatory for compliance; lead site-specific Change Controls.
Seniority
Senior Director, strategic leadership with hands-on technical oversight