Associate Director, Radiopharmaceutical Manufacturing Operations

About the role

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.

Install 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.

Responsibilities

• 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.
• Install 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.

Requirements

• 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

Qualifications

• 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

Skills

• Strong leadership and management skills
• Ability to build and manage multi-level teams
• Experience in GMP environments
• Strong communication and interpersonal skills
• Proven track record in regulatory compliance and audit readiness
• Ability to drive continuous improvement and innovation

Benefits

RayzeBio offers a comprehensive benefits package that includes:

• 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: Paid time off, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day