# Senior Manager of CMC - Quality Assurance

Hiring organization: [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb)

Canonical page: https://career.thegoodapps.co/jobs/652e590a-0d4f-4dbb-9891-89ba90f2a95f

Listed on Bristol Myers Squibb's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Indianapolis, IN
- Salary: 141515 – 171483 USD per year

## Summary

This role oversees quality assurance strategies for radiopharmaceutical manufacturing and analytics across the development lifecycle, from preclinical through post-approval. It suits experienced quality professionals in biologics or sterile drug manufacturing who want to drive CMC strategy and regulatory submissions at a biotech focused on oncology.

_Our summary, not Bristol Myers Squibb's wording._

## Skills named

Change Control, Risk Assessment

## Required

- Bachelor's degree in Chemistry, Biochemistry, or similar scientific field
- Five or more years of hands-on experience in biologics or sterile manufacturing/analytical work in development or operations
- Knowledge of bulk biologic drug substance and radiopharmaceutical development/manufacturing
- Thorough understanding of cGMPs and FDA/EU/ICH regulatory requirements
- Experience bringing multiple INDs through to BLA/NDA approval
- Ability to work in GMP cleanroom environment and handle radioactive materials
- Located at or willing to relocate to Indianapolis manufacturing facility

## Nice to have

- Prior experience in Quality functions
- Experience with monoclonal antibody, bispecific, cell/gene therapy, or radiopharmaceutical manufacturing
- Demonstrated strategic thinking and negotiation skills
- Experience introducing best practices into quality management systems

Apply on Bristol Myers Squibb's site: https://bristolmyerssquibb.wd5.myworkdayjobs.com/en-US/BMS/job/Indianapolis---RayzeBio---IN/Senior-Manager-of-CMC---Quality-Assurance_R1603587