Sr. Scientist, Radiopharmaceuticals
Core
Design, plan, and execute scientific experiments for preclinical development, CMC process development, and scale-up of radiopharmaceuticals.
Role type
Senior Scientist, Radiopharmaceuticals (CMC & Preclinical)
Builds
Radiopharmaceutical drug products and radioisotopes for oncology
Domain
Biopharmaceuticals / Oncology / Radiopharmaceuticals
Required skills
Preclinical development, CMC process development, Technology transfer, Scale-up and automation, Regulatory documentation (IND/NDA), Cross-functional collaboration, Project management, Technical writing, GMP compliance, Radioactive material handling
Preferred skills
AI tools usage, Vendor management, Mentoring
Technologies
Radioisotopes, GMP, FDA/EMA regulations, ICH guidelines
Responsibilities
Design and execute scientific experiments for preclinical development; Drive CMC process development and optimization; Lead technology transfer from preclinical to clinical manufacturing; Design and execute experiments for scale-up and automation; Author technical reports and CMC sections for regulatory filings; Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and R&D teams; Manage research projects and mentor junior scientists.
Seniority
Senior, hands-on IC