Supervisor, Radiopharmaceutical Production

Supervisor, Radiopharmaceutical Production

Objective As a Radiopharmaceutical Production Supervisor you will lead the laboratory procedures and processes involved in the manufacturing process to commercialize investigational drug products. You will be responsible for leading radio chemical synthesis, radiopharmaceutical manufacturing operations, with knowledge of relevant regulations including U.S. FDA 21 CFR 58, laboratory safety, radiation safety, and GMP operations. You will train, mentor, develop, and oversee the production staff in their nightly duties, promoting a culture of continuous improvement in manufacturing procedures.

You will be responsible for collaborating with Quality, Facilities, Safety, and other departments to promote cross‑functional teamwork and cooperation on action plans/project management.

You will possess strong leadership skills, technical experience in a radiopharmaceutical or pharmaceutical manufacturing environment, and a keen understanding of regulatory compliance in the production of radiopharmaceuticals. You will have proven supervisory experience (hiring, training, performance management, staff development) along with excellent production operations and extensive knowledge of quality control, ensuring the safe and efficient manufacturing of high‑quality radiopharmaceutical products. This is a hands‑on role and as production sites and trials expand, there will be opportunities for managerial responsibilities.

Manage the daily operations of the radiopharmaceutical production line(s) during the night shift, ensuring all processes are performed according to standard operating procedures (SOPs), safety guidelines, and regulatory requirements. Maintain accurate record keeping in accordance with GMP. Ensure cross training, scheduling and coverage are obtained on multiple production lines. Initiate discipline if necessary.

Lead and mentor a team of production technicians, ensuring effective communication, teamwork, and a positive work environment. Provide training and support to team members on SOPs, GMP standards, and safety protocols. Provide opportunities for both professional and personal staff development, succession planning, etc.

Ensure compliance with Good Manufacturing Practices (GMP), cGMP, and all regulatory requirements. Oversee the monitoring of product quality and ensure that all produced radiopharmaceuticals meet the required specifications before release.

Collaborate with the production planning team and Site Leader to ensure that production schedules are adhered to, and that resources (materials, equipment, personnel) are appropriately allocated to meet production targets.

Address, resolve and document any production issues that arise during the night shift, including equipment malfunctions, production delays, or quality concerns. Escalate issues when necessary to ensure timely resolution.

Ensure all safety protocols, particularly those related to radiation safety, hazardous materials, and equipment operation, are followed. Promote a culture of safety within the team and ensure all team members are trained and compliant with safety regulations.

Maintain accurate and up‑to‑date records of production activities, including batch records, production logs, quality control documentation, and any incidents or deviations. Report key metrics and production performance to upper management.

Actively participate in initiatives to improve production efficiency, reduce waste, and increase output while maintaining the highest quality standards. Provide feedback to the management team on process improvements and operational efficiency.

• Strong leadership and team management skills, with a proven ability to motivate and guide production teams.
• Excellent problem‑solving and troubleshooting abilities, particularly in high‑stakes production environments.
• Proficient in the use of production software and documentation management…