Senior Radiopharmaceutical Development Lead, CMC

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

Job summary

RayzeBio in Indianapolis is seeking a Senior Manager, Radiopharmaceutical Development/CMC to lead end-to-end drug product development, formulation optimization, IND-enabling studies, and scale-up for GMP manufacturing of radiopharmaceuticals.

You will coordinate cross-functionally with discovery, CMC, regulatory, quality, and clinical teams to advance projects from bench to clinic while mentoring scientists and contributing to regulatory filings.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
• 8+ years in drug development/manufacturing/CMC in pharma, preferably radiopharmaceuticals.
• Experience with IND-enabling studies and regulatory submissions (IND/NDA).
• Experience with technology transfer from preclinical to clinical manufacturing.

Responsibilities

• Provide leadership across RayzeBio's drug product development, scaling, and GMP manufacturing operations.
• Lead and execute scientific experiments for radiopharmaceutical drug product development and API manufacturing.
• Drive technology transfer across development stages ensuring seamless transitions.
• Collaborate with Engineering/Operations to define specs and equipment design.
• Investigate deviations and drive corrective actions and continuous improvement.
• Prepare technical reports and regulatory documents (CMC sections for FDA/EMA submissions).
• Coordinate with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to meet milestones.
• Mentor junior scientists and foster scientific excellence.
• Support commercialization activities for radiopharmaceutical products.

Skills

GMP regulations knowledge

Project management

Cross-functional collaboration

Technical writing

Radiopharmaceuticals experience

AI to improve execution

Education

Ph.D., M.S., or B.S. in Chemistry/ Chemical Engineering/ Pharmaceutical Sciences

Tools

Automated synthesis platforms

Hot cell environments

Job description

RayzeBio in Indianapolis is seeking a Senior Manager, Radiopharmaceutical Development/CMC to lead end-to-end drug product development, formulation optimization, IND-enabling studies, and scale-up for GMP manufacturing of radiopharmaceuticals.

You will coordinate cross-functionally with discovery, CMC, regulatory, quality, and clinical teams to advance projects from bench to clinic while mentoring scientists and contributing to regulatory filings.