Principal Radiopharmaceutical CMC Scientist

Bristol Myers Squibb EU Policy; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Senior Manager, Radiopharmaceutical Development/CMC in Indianapolis. You will lead end‑to‑end drug product development, scale‑up, and GMP manufacturing, coordinating with discovery, regulatory, quality, and clinical teams to advance radiopharmaceutical programs toward clinical and commercial readiness.

You will mentor scientists, drive IND‑enabling studies, and contribute to regulatory filings with strong technical writing and

Qualifications

• Pharmaceutical development experience with GMP and regulatory filings.
• Proven track record leading IND‑enabling studies and regulatory support.
• Experience with technology transfer and manufacturing scale‑up.

Responsibilities

• Provide scientific leadership across RayzeBio's drug product development platform, driving end‑to‑end process development, scale‑up, and GMP manufacturing.
• Lead design and execution of experiments for development, scale‑up and automation of radiopharmaceutical processes.
• Drive technology transfer from preclinical to clinical manufacturing environments.
• Partner with Engineering and Operations to define user requirements and technical specifications.
• Investigate gaps via root cause analysis and implement corrective actions for continuous improvement.
• Author technical reports and regulatory documents to support CMC, IND and NDA submissions.
• Collaborate with Regulatory, Quality, Supply Chain, Clinical and R&D teams for milestone alignment.
• Mentor junior scientists and foster a culture of scientific excellence and rigor.
• Support commercialization activities for transition to commercial‑scale manufacturing.
• Travel up to 20% as required.

Skills

GMP regulations

Project management

Cross-functional collaboration

Technical writing

Radiopharmaceuticals

AI decision-making

Education

PhD, MS, or BS in Chemistry / Chemical Engineering / Pharmaceutical Sciences

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Senior Manager, Radiopharmaceutical Development/CMC in Indianapolis. You will lead end‑to‑end drug product development, scale‑up, and GMP manufacturing, coordinating with discovery, regulatory, quality, and clinical teams to advance radiopharmaceutical programs toward clinical and commercial readiness.

You will mentor scientists, drive IND‑enabling studies, and contribute to regulatory filings with strong technical writing and