Senior Director, Process Development – CGT Drug Product
Core
Lead drug product process development for cell and gene therapies from early development through commercialization, focusing on formulation, cryopreservation, fill and finish, and administration-ready product presentation.
Role type
Senior Director, Process Development (Cell & Gene Therapies)
Builds
Integrated drug product capabilities for autologous and allogeneic cell and gene therapy programs
Domain
Biopharmaceuticals / Advanced Therapies / Cryobiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (specifically: drug product processes, formulation, cryopreservation, fill and finish)
Required skills
Strategic leadership for cross-functional programs, formulation and cryopreservation development, aseptic fill and finish process design, technology transfer to GMP facilities, CDMO governance, Quality by Design principles, lifecycle management, regulatory submission support (IND/BLA/MAA), team building and development, budget management, risk assessment and control strategy definition
Preferred skills
Experience with both autologous and allogeneic modalities, biologics drug product expertise, closed-system processing, cold-chain logistics integration, device and administration system integration
Technologies
Cryobiology tools, aseptic processing equipment, closed-system processing technologies, automation and robotics for manufacturing
Responsibilities
Set scientific and technical strategy for drug product process development, lead process characterization and validation readiness, oversee aseptic fill and finish processes, guide CDMO selection and qualification, partner with Quality and Regulatory on compliance strategies, support CMC regulatory submissions, build and lead high-performing technical teams, establish project plans and operating budgets
Seniority
Senior Director, strategic leadership with hands-on technical oversight
