Sr. Scientist, Radiopharmaceuticals

Role: Senior Scientist in Radiopharmaceuticals responsible for advancing scientific and technical projects supporting development and commercialization of radiopharmaceutical drugs. Responsibilities include designing experiments for preclinical development, leading process development and scale-up for drug products and radioisotopes, managing technology transfer from preclinical to clinical stages, interpreting data for regulatory submissions, authoring technical and regulatory documentation, and collaborating with cross-functional teams (Regulatory, Quality, Supply Chain, R&D). The role also involves vendor management and mentoring junior staff, with a focus on ensuring compliance with GMP and regulatory standards (FDA/EMA). Qualifications: Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; 5+ years of experience in drug development, manufacturing, or CMC, preferably in radiopharmaceuticals. Skills include strong knowledge of GMP, regulatory guidelines, technical writing, project management, and problem-solving. The position requires up to 20% travel, working in a laboratory environment with radioactive materials, and utilizing AI tools for productivity. High-value specifics: focus on radiopharmaceutical development, CMC, IND/NDA regulatory support, and cross-functional collaboration for oncology therapies; located in Indianapolis, with hybrid work arrangements.