Senior Manager of CMC - Quality Assurance

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emerging biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.
Learn more about Rayze Bio:

The Senior Manager of Chemistry, Manufacturing & Controls (CMC) – Quality Assurance develops and drives quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in development (radiopharmaceuticals). The emphasis of the position will be at the Indianapolis manufacturing facility and therefore the incumbent must be located at the site. The incumbent will be responsible for multiple projects, which may be at the Indianapolis site, San Diego, and/or CMOs.

• Member of CMC Development Teams providing quality (QA) input from pre‑clinical to end of product life cycle, including NDA filing, other market filings, and post‑approval changes. Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.
• Responsible for change control management for compound/product‑specific changes through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate and compound/product specific, responsible quality member for oversight and QA approver of all key quality system deliverables associated with the drug development candidate including deviations, investigations, CAPAs, and complaints.
• Review and approve compound/product‑specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports), including stability.
• Work with CMC Teams to conduct compound/product‑specific risk assessments, as required, for all aspects of the drug development process. Responsible for communicating quality risks within the quality organization.
• Collaborate with regulatory to track/own quality input for ongoing regulatory filings and updates to health authorities (e.g., IND/IMPD/BLA/NDA) including specifications, shelf‑life extensions, country specific trial approvals, etc.
• Perform other tasks as assigned (e.g., final quality reviewer/approver of quality events and/or GMP documentation, actively contribute to ongoing investigations as required).

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar scientific field.
• Five plus years of hands‑on biologics/sterile experience within a development/operations facility—manufacturing and/or analytical. (An equivalent combination of education and experience may be substituted.)

• Prior experience in quality.

• Thorough knowledge of the pharmaceutical development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval. Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold‑chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.
• Recognized as a CMC expert in radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.
• Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
• Well‑versed in relevant CMC area, with an ability to introduce quality‑relevant (phase‑appropriate) best practices into the CMC development processes.
• Excellent investigational and QA problem‑solving skills. Analytical mindset, with an ability to assess new situations to define…