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 Therapy)
Builds
Integrated drug product capabilities for autologous and allogeneic cell and gene therapy programs
Domain
Biopharmaceuticals / Advanced Therapies / Cell & Gene Therapy
Required skills
Drug product process development, Cryopreservation, Formulation development, Fill and finish processes, Aseptic processing, Technology transfer, Quality by Design, Lifecycle management, CDMO governance, Regulatory submissions (CMC)
Preferred skills
Autologous cell therapy experience, Allogeneic cell therapy experience, Biologics drug product experience, Cold-chain logistics integration, Device/administration system integration
Technologies
Controlled-rate freezing, Closed-system processing, Container closure systems, Automation
Responsibilities
Establish integrated process development strategy, Lead formulation and cryopreservation development, Oversee aseptic fill and finish processes, Define scalable drug product processes, Ensure integration between upstream and drug product operations, Drive process characterization and validation, Lead technology transfer, Provide technical oversight for manufacturing, Guide selection of CDMOs and vendors, Partner on regulatory submissions, Build and lead high-performing teams
Seniority
Senior Director, strategic leadership & team building