CMC QA Lead – Radiopharmaceuticals (Indy)

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

Benefits offered by this job

Flexible Time Off

11 paid holidays

Wellbeing support

Retirement plan

Medical/dental/vision insurance

Stock opportunities

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary in Indianapolis, seeks an Associate Director of CMC - Quality Assurance. You will lead QA strategies for drug substance, API, and analytics across development, with the role focused on CMC at the Indianapolis site and potential collaboration with other locations.

You must have a strong background in radiopharmaceuticals/biologics, experience with cGMPs, and a track record bringing INDs through BLA/NDA.

Qualifications

• Thorough knowledge of Pharmaceutical Development processes evidenced by INDs to BLA/NDA approvals.
• Knowledge of bulk biologic drug substance and radiopharmaceutical development/manufacturing.
• Regulatory and QA collaboration across development stages.

Responsibilities

• Provide QA input from pre-clinical to end of product life cycle, including NDA filings.
• Develop and approve CMC strategy for DS/DP/analytical aspects with SMEs.
• Manage change control for compound/product changes through lifecycle.
• QA reviewer/approver for Quality events and investigations as needed.
• Review analytical method lifecycle documents and stability data.
• Conduct risk assessments for drug development processes as required.
• Collaborate with Regulatory on inputs for IND/IMPD/BLA/NDA updates.
• Contribute to continuous improvement within QA and CMC teams.

Skills

CMC Development

Radiopharmaceuticals

cGMPs

Regulatory Liaison

Quality Assurance

Education

B.S. in Chemistry/Biochemistry

Job description

RayzeBio, a Bristol Myers Squibb subsidiary in Indianapolis, seeks an Associate Director of CMC - Quality Assurance. You will lead QA strategies for drug substance, API, and analytics across development, with the role focused on CMC at the Indianapolis site and potential collaboration with other locations.

You must have a strong background in radiopharmaceuticals/biologics, experience with cGMPs, and a track record bringing INDs through BLA/NDA.