Senior Director, Site Manufacturing Science and Technology, Cell Therapy Technical Operations
Core
Senior technical leader for cell therapy manufacturing sites, overseeing process transfer, validation, commercial supply, and continuous improvement.
Role type
Senior Director, Site Manufacturing Science and Technology (Cell Therapy)
Builds
Cell therapy products for clinical and commercial supply
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy manufacturing processes, GMP operations, process validation, commercial supply management, team leadership, regulatory compliance (cGMP/ICH), change control management, risk mitigation, technology transfer, process improvement (PPA/CPV)
Preferred skills
Experience with biologics, viral vectors, or vaccines
Technologies
GMP manufacturing systems, CMC documentation tools, process analysis frameworks
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 PPA and CPV strategies; serve as accountable leader for regulatory submissions (INDa, BLA, MAA); lead site preparedness for health authority inspections; develop scientific justifications for site operations and changes.
Seniority
Senior Director, strategic leadership with hands-on technical oversight