Principal Scientist, Radiopharmaceutical Development/CMC
Core
Leading end-to-end process development, scale-up, and technology transfer for radiopharmaceutical drug products from preclinical to commercial manufacturing.
Role type
Principal Scientist, Radiopharmaceutical Development/CMC
Builds
Robust, repeatable GMP manufacturing operations for novel radiopharmaceutical therapies
Domain
Oncology / Radiopharmaceuticals / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Radiopharmaceutical formulation development, Process development and scale-up, GMP manufacturing, IND-enabling studies, Technology transfer, Root cause analysis, Regulatory submissions (IND/NDA), Hot cell operations, Automated synthesis platforms, Radionuclide handling (alpha/gamma)
Preferred skills
AI application for team execution, Cross-functional collaboration
Technologies
Automated synthesis platforms, Hot cell environments
Responsibilities
Provide scientific and technical leadership across drug product development platform, Lead and execute experiments for process development and scale-up, Drive technology transfer from preclinical to clinical manufacturing, Partner with Engineering to define user requirements and equipment specifications, Investigate manufacturing gaps and lead corrective actions, Author technical reports for regulatory filings, Mentor junior scientists, Support commercialization transition
Seniority
Principal, hands-on IC with strategic leadership
