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 & Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
Cell therapy manufacturing processes, GMP operations, process validation (PPQ), continued process verification (CPV), CMC regulatory submissions, team leadership, strategic planning, risk mitigation, change control management
Preferred skills
Experience with biologics, viral vectors, or vaccines, advanced degree in engineering/biology
Technologies
cGMP, ICH guidelines, validation master plans, health authority inspection protocols
Responsibilities
Define and execute global MSAT function strategy; build and mentor high-performing technical teams; oversee technology transfer and process characterization; lead regulatory submission CMC sections; manage post-approval process optimization and comparability strategies; drive process improvements for robustness and cost; lead health authority inspections and audits.
Seniority
Senior Director, executive-level leadership