Senior Manager of CMC - Quality Assurance

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, RayzeBio 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 RayzeBio: Position Overview 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. Job Responsibilities 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). Education & Experience 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.) Preferred Education & Experience Prior experience in quality. Skills & 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 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 and implement the appropriate QA action plan. Ability to work independently, yet effectively in a team environment. Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast‑paced environment. Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory). Applies AI to improve team execution and decision‑making. Other proven competencies such as strategic thinker, influencer and negotiator are required. Continuous improvement mindset is also required. Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials. Work Environment The noise level in the work environment is usually moderate. Work‑related travel outside Indianapolis, Indiana, may be required up to 20% of working time (e.g., 10 weeks per year). Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Paid Time Off: US exempt employees have flexible time off (unlimited, with manager approval) plus 11 paid national holidays. Non‑exempt and hourly employees receive 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual global shutdown between Christmas and New Year’s Day. Equal Opportunity & Disability BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable accommodation before accepting a job offer. For more information, visit careers.bms.com/eeo-accessibility. Candidate Rights & Data Protection BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws. We will never request payments, financial information, or social security numbers during our application or recruitment process. 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