Director, CMC

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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 the 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 Director of CMC will lead and oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) activities to support the development and commercialization of drug products. This role is critical in ensuring compliance with regulatory requirements, optimizing manufacturing processes, and aligning CMC strategies with the overall business and clinical development objectives.

Job Responsibilities:

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

CMC Strategy & Leadership

·Develop and execute a comprehensive CMC strategy to support clinical and commercial drug development.

·Collaborate cross-functionally with Regulatory, Quality, Supply Chain, Clinical, and R&D teams to ensure alignment with corporate goals.

·Serve as the primary CMC expert for regulatory filings, interactions with health authorities (e.g., FDA, EMA), and due diligence activities.

·Provide leadership and mentorship to internal and external teams working on CMC-related projects.

Process Development & Manufacturing

·Oversee drug substance (API) and drug product development, scale-up, technology transfer, and manufacturing at external CMOs/CDMOs.

·Ensure process optimization, validation, and tech transfer activities meet quality, cost, and timeline objectives.

·Drive risk assessment and mitigation strategies for manufacturing challenges.

Regulatory & Compliance

·Lead the CMC regulatory strategy and contribute to IND, IMPD, BLA/NDA, and other global submissions.

·Ensure compliance with GMP, ICH guidelines, and regulatory requirements for manufacturing and quality control.

·Serve as the key liaison for regulatory agency interactions related to CMC topics.

Quality & Supply Chain Support

·Partner with Quality teams to establish CMC-related quality systems and oversight for manufacturing partners.

·Support supply chain management by ensuring reliable production and timely delivery of clinical and commercial materials.

·Identify and manage strategic external CMO/CDMO partnerships for supply continuity.

Education and Experience:

·Ph.D., M.S., or B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.

·10+ years of experience in CMC, process development, manufacturing, or related fields in the biopharmaceutical industry.

Skills and Qualifications:

·Proven track record in late-stage development, regulatory submissions (IND, NDA, BLA), and commercial launch.

·Strong understanding of GMP, FDA/EMA regulations, and ICH guidelines.

·Experience in working with external manufacturing partners (CMOs/CDMOs).

·Excellent project management, leadership, and cross-fu