Job Description Summary

The Head of Manufacturing Sciences and Technology (MST) for Radiotracers will lead the technical operations and scientific oversight of the manufacturing of radiotracers, ensuring compliance with 21 CFR 212 and board of pharmacy regulations. This role will involve close collaboration with contract manufacturers, radiopharmacies, and process development teams to ensure the successful tech transfer, troubleshooting of equipment and process issues, and overall product quality and safety. The ideal candidate will drive the execution of technical and product risk assessments, manage the troubleshooting of technical issues, and lead efforts to continuously improve manufacturing processes.

Job Description

Key Responsibilities:

• Leadership and Oversight:
  • Lead and oversee the manufacturing sciences and technology team for radiotracer production in compliance with 21 CFR 212.
  • Provide strategic direction and technical guidance to ensure effective manufacturing of radiotracers.
  • Drive technical excellence within the department and ensure the highest levels of performance and efficiency.
• Collaboration with External Partners:
  • Serve as the primary technical liaison between internal teams and contract manufacturers or radiopharmacies.
  • Lead technical and scientific collaboration to ensure smooth tech transfers, scale-up, and consistent quality production at external manufacturing sites.
  • Ensure that external partners are compliant with applicable regulations and internal quality standards.
• Tech Transfer Management:
  • Lead and manage the tech transfer process for radiotracers, ensuring all aspects of the process, from development to manufacturing, are appropriately transferred, validated, and optimized.
  • Coordinate with cross-functional teams (e.g., Process Development, Quality, Regulatory) to ensure seamless transitions during tech transfers.

• Troubleshooting and Process Optimization:
  • Provide technical leadership in troubleshooting equipment and process-related issues at internal and external sites.
  • Identify and resolve challenges related to production processes, equipment performance, and quality deviations.
  • Lead continuous improvement initiatives to optimize manufacturing efficiency and product quality.
• Risk Management:
  • Conduct technical and product risk assessments for quality deviations and manufacturing issues.
  • Collaborate with quality teams to implement corrective actions, manage risk mitigation strategies, and ensure ongoing compliance with regulatory standards.
  • Support CAPA (Corrective and Preventive Action) activities and investigations related to product quality and process performance.
• Regulatory Compliance:
  • Ensure that all manufacturing processes, including tech transfers and product development, comply with FDA regulations (21 CFR 212), board of pharmacy and other applicable regulatory requirements.
  • Lead the preparation for regulatory inspections, audits, and submissions, ensuring all necessary documentation is in place and compliant with relevant guidelines.
• Team Leadership and Development:
  • Build and lead a high-performing MST team, fostering a culture of collaboration, innovation, and continuous improvement.
  • Mentor and develop team members, ensuring they have the skills and knowledge necessary to meet organizational goals and maintain compliance with industry standards.
• Documentation and Reporting:
  • Oversee the preparation and review of technical documentation, including batch records, reports, validation protocols, and regulatory submissions.
  • Ensure all technical documentation is complete, accurate, and up to date in line with regulatory requirements.

Qualifications:

• Education:
  • PhD, Pharmacy, Master’s, or Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• Experience:
  • Minimum 10 years of experience in the manufacturing or technical operations of radiopharmaceuticals or biologics, with a focus on radiotracers and compliance with 21 CFR 212.
  • Proven experience in managing tech transfers and collaborating with contract manufacturers and external radiopharmacies.
  • Expertise in troubleshooting manufacturing processes, equipment, and resolving technical challenges.
  • Strong experience in conducting risk assessments, CAPA activities, and managing product quality deviations.
• Skills:
  • Strong knowledge of FDA regulations (21 CFR 212), Board of Pharmacy & cGMP compliance.
  • Excellent problem-solving, crit