Associate Director of CMC - Quality Assurance

$164.84k - $199.75k

Bristol Myers Squibb

Bristol Myers Squibb's RayzeBio subsidiary seeks an Associate Director of CMC - Quality Assurance to develop and drive quality strategies for radiopharmaceutical drug development at the Indianapolis manufacturing facility. The role encompasses oversight of manufacturing and analytical activities across the product lifecycle, from preclinical through regulatory filing and post-approval phases.

Responsibilities

Provide quality input for CMC development teams from preclinical through product lifecycle and regulatory filings
Develop and approve CMC strategy for drug substance, drug product, and analytical methods with technical experts
Manage change controls and impact assessments for compounds throughout product lifecycle
Review and approve analytical method documents, specifications, test methods, and stability protocols
Conduct risk assessments and communicate quality risks; collaborate on regulatory submissions to health authorities

Requirements

Bachelor's degree in Chemistry, Biochemistry, or similar scientific field
10+ years hands-on biologics/sterile experience in development or operations facilities
Prior quality assurance experience preferred
Demonstrated expertise bringing multiple INDs through to BLA/NDA approval
Knowledge of bulk biologic drug substances, parenteral forms, and radiopharmaceutical development
Thorough understanding of cGMPs and regulatory requirements (FDA, EU, ICH)
Strong investigational and QA problem-solving skills with analytical mindset

Compensation: $164,838 - $199,745

Apply

Vacancy posted 22 days ago

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