Radiopharmaceuticals Scientist - CMC & Preclinical Leader

Bristol-Myers Squibb Co; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Sr. Scientist, Radiopharmaceuticals in Indianapolis to drive preclinical development, CMC processes, and tech transfer for radiopharmaceuticals.

You will collaborate across Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure robust, compliant programs and successful commercialization. The role requires a Ph.D./MS/BS with 5+ years in drug development or radiopharmaceuticals, strong GMP, regulatory writing, and

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, CMC or related fields in a pharmaceutical industry, preferably radiopharmaceuticals.
• Experience with radiopharmaceuticals is preferred.

Responsibilities

• Design, plan and execute scientific experiments for preclinical development of radiopharmaceuticals.
• Drive CMC process development and optimization for clinical drug products, including formulation lock and robust process definition, ensuring scalability and regulatory compliance.
• Lead technology transfer of drug products and API from preclinical stage to clinical manufacturing.
• Design, plan and execute scientific experiments for scale up and automation of drug products and API manufacturing processes.
• Interpret complex experimental data, communicate findings in technical reports, regulatory documentation, and presentations for internal and external stakeholders.
• Author CMC sections for IND/NDA submissions and support regulatory filings.
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams.
• Manage and mentor junior scientists and oversee third-party vendors.
• Provide support for commercialization of radiopharmaceuticals.
• Uses AI tools to enhance productivity and quality of work.
• Up to 20% of travel required.

Skills

GMP knowledge

FDA/EMA regs

ICH guidelines

Problem solving

Project management

Technical writing

Cross-functional collab

Education

PhD, MS, or BS in Chemistry/Engineering/Pharma

5+ years in drug development/CMC

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Sr. Scientist, Radiopharmaceuticals in Indianapolis to drive preclinical development, CMC processes, and tech transfer for radiopharmaceuticals.

You will collaborate across Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure robust, compliant programs and successful commercialization. The role requires a Ph.D./MS/BS with 5+ years in drug development or radiopharmaceuticals, strong GMP, regulatory writing, and