Head of Radiopharmaceutical Manufacturing

Key Responsibilities

• Lead and manage the day-to-day operations of the radiopharmaceutical manufacturing department, ensuring production efficiency, quality, and compliance with regulatory standards.
• Oversee the manufacturing of sterile injectable radiopharmaceuticals, ensuring adherence to GMP and other industry-specific standards.
• Ensure the smooth transfer of technologies, manufacturing processes, and procedures from development to commercial-scale production, through effective tech transfer.

• Lead the scale-up of radiopharmaceutical manufacturing processes from R&D through to full-scale production.
• Collaborate with R&D, quality, and regulatory teams to optimize processes and improve production efficiency.
• Implement robust process control strategies to scale production without compromising product quality or safety.

• Ensure that all manufacturing processes are properly validated, including process validation, equipment validation, and cleaning validation, in compliance with GMP and regulatory requirements.
• Ensure all relevant documentation for process validation and equipment qualification is generated, maintained, and in compliance with industry standards.
• Oversee the implementation of continuous improvement initiatives to enhance product quality, process consistency, and regulatory compliance.

• Lead, mentor, and develop a high-performing team of manufacturing professionals, fostering a culture of continuous improvement and compliance.
• Manage and optimize team workflows to ensure timely delivery of high-quality radiopharmaceutical products.
• Ensure adequate training and development of team members on GMP, regulatory requirements, and best practices in radiopharmaceutical manufacturing.

• Collaborate with cross-functional teams, including R&D, quality assurance, regulatory affairs, and supply chain to ensure seamless tech transfer and manufacturing scalability.
• Liaise with regulatory bodies to ensure compliance with applicable laws and guidelines.
• Provide expertise and recommendations to senior leadership on manufacturing strategy and operations.