CMC & QA Leader — Radiopharmaceuticals Development

Bristol-Myers Squibb Co; Indianapolis (IN); On-site; USD 142,000 - 171,000; Full time

Benefits offered by this job

Health Coverage

401(k) plan

Paid time off

Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Senior Manager of Chemistry, Manufacturing & Controls (CMC) – Quality Assurance at the Indianapolis facility. Lead QA input across DS/DP/analytical strategy and ensure compliant life-cycle management for radiopharmaceuticals.

You will collaborate with Regulatory and SMEs, drive change control, and review analytical method life-cycle documentation to support NDA/BLA filings and post‑approval changes.

Qualifications

• Thorough knowledge of pharmaceutical development and CMC processes.
• Experience with QA input from pre-clinical to post-approval changes.
• Familiarity with FDA/ICH guidance and regulatory submissions.

Responsibilities

• Provide QA input for CMC development from pre-clinical to product life cycle.
• Develop and approve CMC strategy for DS/DP/analytical methods.
• Oversee change control and QA sign-off of key deliverables.

Skills

CMC/QA Experience

GMP Regulatory Knowledge

Analytical Method Validation

Education

Bachelor's degree in Chemistry or Biochemistry

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, seeks a Senior Manager of Chemistry, Manufacturing & Controls (CMC) – Quality Assurance at the Indianapolis facility. Lead QA input across DS/DP/analytical strategy and ensure compliant life-cycle management for radiopharmaceuticals.

You will collaborate with Regulatory and SMEs, drive change control, and review analytical method life-cycle documentation to support NDA/BLA filings and post‑approval changes.