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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Associate Director 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.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• 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 proactive Initiatives, 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.

• Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).

Education and Experience

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.   

• Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).

• Prior experience in Quality is preferred.

• An equivalent combination of education and experience may be substituted

Skills and Qualifications

• 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