**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 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 Suppor t · 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-functional collaboration skills. · Strong problem-solving abilities and the ability to manage multiple projects in a fast-paced environment. · Expertise in radiopharmaceuticals. · Prior experience in leading CMC teams and regulatory interactions. · Knowledge of analytical development, stability studies, and quality control. \#RayzeBio The starting compensation for this job is a range from $206,268-$249,900, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is 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 workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1589427 **Updated:** 2025-02-17 05:19:34.409 UTC **Location:** San Diego-CA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.