Radiopharmaceutical Development Leader, CMC & IND

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

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) / Retirement plans

Paid Time Off

Stock options

Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Principal Scientist in Radiopharmaceutical Development/CMC to drive pre-clinical through lifecycle management of radiopharmaceuticals for clinical use. You will lead end-to-end process development, scale-up, and regulatory support across global filings.

The role emphasizes technology transfer, cross-functional collaboration, and preparation of regulatory documents for IND and NDA submissions, with travel up to 20%.

Qualifications

• PhD/MS/BS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with industry experience.
• Experience in radiopharmaceutical formulation and process development and GMP manufacturing.
• Led IND-enabling studies and supported regulatory submissions (IND/NDA).

Responsibilities

• Provide scientific and technical leadership across drug product development, capex, and GMP manufacturing.
• Lead experiments for development, scale-up, and automation of radiopharmaceutical manufacturing processes.
• Drive technology transfer from preclinical to clinical manufacturing stages.
• Collaborate with Engineering to define requirements and equipment specs.
• Investigate gaps via root cause analysis and drive corrective actions.
• Author reports and source documents for regulatory filings (FDA IND/NDA, EMA, Health Canada).
• Coordinate with Regulatory, Quality, Supply Chain, Clinical, and R&D teams for milestones.
• Mentor junior scientists and foster scientific excellence.
• Support commercialization transitions from clinical to manufacturing scale.
• Travel up to 20% as needed.

Skills

GMP knowledge

Regulatory acumen

Project leadership

Cross-functional collaboration

Technical writing

Problem solving

AI for team execution

Education

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

Tools

Automated synthesis platforms

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Principal Scientist in Radiopharmaceutical Development/CMC to drive pre-clinical through lifecycle management of radiopharmaceuticals for clinical use. You will lead end-to-end process development, scale-up, and regulatory support across global filings.

The role emphasizes technology transfer, cross-functional collaboration, and preparation of regulatory documents for IND and NDA submissions, with travel up to 20%.