Senior CMC QA Lead – Radiopharmaceuticals

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Flexible Time Off

Stock opportunities

Discretionary incentive cash

11 paid company holidays

Job summary

RayzeBio in Indianapolis, IN is seeking an Associate Director of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics across development, with emphasis on radiopharmaceuticals.

This senior role requires deep CMC expertise and cross‑functional collaboration with Regulatory and QA teams, and is based at the Indianapolis site with responsibility for multiple projects.

Qualifications

• B.S. degree in Chemistry, Biochemistry or similar field.
• 10+ years of hands-on biologics/sterile experience in development/operations.
• Experience in Quality is preferred.
• Equivalent combination of education and experience may be substituted.

Responsibilities

• Provide QA input from pre-clinical to end of product life cycle.
• Oversee change control for compound/product changes through lifecycle.
• Review and approve analytical method lifecycle documents (API, DP, stability).
• Conduct risk assessments for drug development processes.
• Collaborate with Regulatory on filings and Health Authority updates.
• Act as QA reviewer/approver for Quality events and investigations.

Skills

CMC expert

Regulatory knowledge

GMP compliance

Radiopharmaceuticals

Biologics

Analytical problem-solving

Team collaboration

AI in QA

Education

Bachelor's degree in Chemistry/Biochemistry or similar

Job description

RayzeBio in Indianapolis, IN is seeking an Associate Director of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics across development, with emphasis on radiopharmaceuticals.

This senior role requires deep CMC expertise and cross‑functional collaboration with Regulatory and QA teams, and is based at the Indianapolis site with responsibility for multiple projects.