Senior Manager of CMC - Quality Assurance

Requirements

• Recognized as a CMC expert, 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 emp

Benefits

Additional Information

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 emergent 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: https://careers.bms.com/rayzebio/ 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 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, 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. 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 and Experience Prior experience in Quality

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