Associate Director, Radiopharmaceutical Manufacturing Operations Indianapolis - RayzeBio - IN R1605751 Posted

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio:

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 Rayze Bio'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.

• 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 clean rooms, 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…