Manager, Technology Transfer & CDMO Operations
Core
Lead end-to-end technology transfer of radiopharmaceutical processes from internal development to external CDMO partners and manage clinical supply chain operations.
Role type
Manager, Technology Transfer & CDMO Operations
Builds
Radiopharmaceutical drug products for clinical trials
Domain
Biopharmaceuticals / Radiopharmaceuticals / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technology transfer management, CDMO relationship management, Clinical supply chain oversight, Regulatory compliance (GMP/IND), Technical package development, Vendor qualification, Project management, CMC documentation
Preferred skills
International CDMO management, Radiopharmaceutical manufacturing experience, Supply chain logistics, PMP certification
Technologies
MS Project, Smartsheet
Responsibilities
Develop and execute technology transfer plans and timelines, Manage day-to-day CDMO relationships and performance, Coordinate clinical supply chain logistics and inventory, Partner with Regulatory and Quality teams for compliance, Lead negotiation of Quality Agreements and Technical Packages, Author CMC documentation for regulatory submissions, Support vendor selection and due diligence, Maintain project plans and risk registers for multiple programs
Seniority
Manager, hands-on IC
