CMC Synthetics Clinical Manufacturing Leader
Core
Coordinate and oversee internal and external GMP clinical manufacturing activities to supply clinical trials with drug substance and drug product.
Role type
Senior IC clinical manufacturing team leader (CMC synthetics)
Builds
Clinical drug substance and drug product batches for clinical trials
Domain
Biopharmaceuticals / Clinical Manufacturing / CDMO Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, CDMO selection and management, process transfer coordination, quality event tracking, sourcing strategy, batch record review
Preferred skills
Cross-functional collaboration, complex environment prioritization, proposal development
Technologies
GMP systems, CDMO platforms
Responsibilities
Lead sourcing strategy for internal vs external manufacturing, coordinate planning alignment between internal and external activities, review and approve GMP documents, ensure tracking of quality events, support vendor management for US-based CDMOs, act as local representative for Project Oversight and External Technologies teams
Seniority
Senior, hands-on IC