Associate Director, Radiopharmaceutical Manufacturing Operations

Job description

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 Associate Director, Radiopharmaceutical Manufacturing Operations will provide strategic and operational leadership over drug product production, managing a team of Production Managers and Supervisors across a GMP radiopharmaceutical manufacturing site. As a member of the SLT, this role will set the vision and drive a culture of compliance, safety, and continuous improvement across manufacturing operations. The Associate Director will build a high-performing, well-trained organization with a strong emphasis on compliance and EH&S, establishing organizational development and training programs for operators and manufacturing staff. The Associate Director will partner with Quality, Supply Chain, Engineering, and Regulatory leadership to establish departmental strategy, budgets, staffing plans, and KPI's, and to ensure clearly defined roles and accountabilities across the organization. This role will work cross functionally and with senior leadership to meet corporate objectives, support inspection readiness, and support both commercial and R&D related manufacturing activities as part of the scale-up and commercialization of RayzeBio's programs. The Associate Director will instill a continuous improvement culture, along with the systems needed to sustain it, and will build, coach, and manage a high-performing manufacturing leadership team to ensure a consistent, compliant, and timely global supply chain is achieved. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Provide strategic and in-plant leadership and guidance for production managers, supervisors, and personnel, and ensure GMP compliance for clinical and commercial drug product production. Own the manufacturing department budget and headcount plan, and oversee external cleaning vendors and other support vendors related to GMP cleanroom operations, including contract negotiation and performance management. Develop and implement a robust employee training and organizational development program for operators and manufacturing staff, with a strong emphasis on compliance and EH&S, and build organizational and succession plans for the manufacturing leadership team. Review and approve GMP documentation including but not limited to Batch Records, SOP's, forms, Deviations, CAPA's, Change Controls and reports, ensuring alignment with regulatory commitments and audit readiness. Own investigations related to manufacturing deviations, drive root cause analysis, and implement effective corrective and preventative action plans, escalating cross-functionally as needed. Lead the build-out of the manufacturing organization, including drafting job descriptions, and interviewing and hiring of managers, supervisors, and personnel. Conduct performance reviews for direct reports and lead employee development and talent management programs across the manufacturing organization. Establish and report manufacturing department KPI's related to performance, throughput, and cost of GMP radiopharmaceutical operations to senior leadership. Oversee validation activities related to hot cells and production cleanrooms, and lead technology transfer and capital project initiatives supporting new products and facility expansion. Ensure compliance with NRC, EH&S and US/EU GMP regulatory guidelines, and serve as manufacturing lead/subject matter expert during regulatory agency inspections and audits. Represent Manufacturing on the site leadership team, contributing to long-range capacity planning, budget cycles, and strategic decision-making for radiopharmaceutical operations. Instill a continuous improvement culture across manufacturing operations, and establish the systems, metrics, and governance needed to sustain it over time. Support both commercial and R&D related manufacturing activities, partnering with Process Development and Clinical Supply teams to enable technology transfer and new product introduction. Education and Experience BS or MS in a scientific, engineering, or related field required; advanced degree preferred, or equivalent work experience 12+ years of experience in Radiopharmaceutical or injectable GMP manufacturing environment, including 5+ years leading managers or supervisors within a manufacturing organization. Skills and Qualification Highly motivated, strategic leader with strong interpersonal, communication, and executive presentation skills. Proven experience building and managing multi-level teams, including managers and supervisors, in a GMP environment, along with budget and resource planning experience. Excellent professional ethics, integrity, and ability to maintain confidential information. Direct experience hosting or supporting NRC, FDA, and/or EU regulatory agency inspections. Applies AI to improve team execution and decision‑making Physical DemandsWhile 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 is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials. Work Environment The noise level in the work environment is usually moderate. #LI-Onsite 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. Compensation Overview: Indianapolis - RayzeBio - IN: $164,838 - $199,745 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as 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. ​Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires w