Senior Manager, Radiopharmaceutical Development/CMC
Core
Lead end-to-end process development, scale-up, and technology transfer for radiopharmaceutical drug products and APIs from preclinical through clinical manufacturing stages.
Role type
Senior Manager (Principal Scientist), Radiopharmaceutical Development/CMC
Builds
Robust, repeatable GMP manufacturing operations for novel radiopharmaceutical therapies
Domain
Oncology / Radiopharmaceuticals / Chemical Engineering
Deliverable
production ML models
Required skills
GMP manufacturing, process development, scale-up, technology transfer, regulatory submissions (IND/NDA), root cause analysis, technical writing, project management, cross-functional collaboration, mentoring
Preferred skills
Hot cell environment experience, automated synthesis platforms, alpha/gamma emitting radionuclides, AI application for team execution
Technologies
Automated synthesis platforms, hot cell environments
Responsibilities
Provide scientific and technical leadership across drug product development platform; Lead, design, plan, and execute scientific experiments for manufacturing processes; Drive technology transfer from preclinical to clinical stages; Partner with Engineering to define user requirements and influence equipment design; Investigate manufacturing gaps and deviations; Author technical reports for regulatory filings; Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams; Mentor and develop junior scientists; Support commercialization activities
Seniority
Senior Manager, hands-on IC with leadership responsibilities