Note: The job is a remote job and is open to candidates in USA. Barrington James is partnering with a clinical-stage cell therapy company developing allogeneic CAR-T therapies for oncology and autoimmune disease. The Head of Technical Operations will build and lead the Technical Operations function across manufacturing, MSAT, process development, supply chain, and CDMO management, supporting late-stage development and future commercialization.
Responsibilities
- Build and lead the function across Manufacturing, MSAT, Process Development, Supply Chain and CDMO management
Skills
- 15+ years of Technical Operations / CMC leadership
- Strong allogeneic cell therapy experience
- Proven BLA submission and approval experience, including hands-on Module 3 CMC
- Commercial manufacturing / launch experience
- MSAT, process validation and PPQ experience
- Strong CDMO oversight and technology transfer experience
- FDA interactions, inspections and regulatory readiness
- Experience building and scaling Technical Operations organizations
Company Overview