Radiopharmaceutical Development & CMC Lead

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

Benefits offered by this job

Flexible Time Off

Paid vacation

Stock opportunities

Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a senior manager to lead radiopharmaceutical development and CMC activities in Indianapolis. The role drives end-to-end process development, scale-up, and regulatory submissions with global collaboration across Regulatory, Quality, and R&D teams.

Ideal candidates have 8+ years in pharma with radiopharmaceutical expertise, GMP experience, and a track record in IND/NDA support and technology transfer.

Qualifications

• Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with industry experience.
• 8+ years in drug development, manufacturing, CMC or related fields in pharma, preferably radiopharmaceuticals.
• Experience in radiopharmaceutical formulation development and GMP manufacturing.
• IND‑enabling studies and regulatory submissions experience (IND/NDA).
• Technology transfer experience from preclinical to clinical manufacturing.
• Knowledge of GMP, FDA/EMA, ICH guidelines, and NRC requirements.

Responsibilities

• Provide scientific and technical leadership across RayzeBio's drug product development platform, driving end-to-end process development and GMP manufacturing.
• Lead experiments supporting development, scale-up, and automation of radiopharmaceutical drug product and API manufacturing.
• Drive technology transfer from preclinical to clinical manufacturing with process continuity.
• Define user requirements and specifications with Engineering/Operations; influence equipment design and selection.
• Investigate manufacturing gaps via root cause analysis and drive corrective actions and improvements.
• Author reports and documents to support regulatory filings (CMC for IND/NDA and international submissions).
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams.
• Mentor junior scientists and foster scientific excellence and operational rigor.
• Support commercialization activities for radiopharmaceutical products.
• Travel up to 20% as required.

Skills

GMP & regulatory knowledge

Problem solving

Project management

Technical writing

Radionuclides knowledge

AI for decision-making

Education

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

Tools

Automated synthesis platforms

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a senior manager to lead radiopharmaceutical development and CMC activities in Indianapolis. The role drives end-to-end process development, scale-up, and regulatory submissions with global collaboration across Regulatory, Quality, and R&D teams.

Ideal candidates have 8+ years in pharma with radiopharmaceutical expertise, GMP experience, and a track record in IND/NDA support and technology transfer.