Director, Radiopharmaceutical Development

Director, Radiopharmaceutical Development

Our client is an end-to-end contract development and manufacturing organization (CDMO) partner dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies so that radiopharmaceutical companies and other innovators can succeed.

The Director, Radiopharmaceutical Development will spearhead the design, development, and optimization of radioligand therapy (RLT) products, driving innovation in synthesis, formulation, and process development. This role will lead a multidisciplinary team to deliver high-quality Chemistry, Manufacturing, and Controls (CMC) data packages for clients, ensuring compliance with regulatory standards and alignment with strategic objectives.

Key Responsibilities

• Lead RLT Product Development : Oversee the technical execution of RLT product development at the Rochester site, ensuring robust and scalable processes for client deliverables.
• Innovate Synthesis and Formulation : Develop and optimize small-scale synthetic processes, methods, and formulations for RLT products, including labeling of small molecules, peptides, and antibodies with therapeutic alpha-emitting (e.g., 225Ac, 212Pb, 211At) and beta-emitting (e.g., 177Lu, 161Tb, 67Cu) radioisotopes.
• CMC Data Package Delivery : Direct the development team in generating comprehensive CMC data packages to meet client and regulatory requirements, ensuring seamless integration into clinical and commercial pipelines.
• Strategic Technical Development : Build and enhance technical expertise to address future radiopharmaceutical needs, including novel isotopes, targeting agents, and advanced delivery systems.
• Team Leadership and Mentorship : Supervise, train, and mentor junior staff and direct reports, fostering a collaborative and innovative team environment to achieve project milestones.
• Project Management Collaboration : Partner with leadership and project management teams to develop project plans, timelines, budgets, and client reports, ensuring alignment with organizational goals.
• Quality and Compliance Support : Assist in investigating and resolving product deviations in the production facility, ensuring adherence to Good Manufacturing Practices (GMP) and regulatory standards.
• Cross-Functional Engagement : Collaborate with internal and external stakeholders, including R&D, manufacturing, and quality assurance teams, to drive project success and innovation.
• Continuous Improvement : Identify opportunities to enhance processes, implement cutting-edge technologies, and improve operational efficiencies in radiopharmaceutical development.
• Additional Duties : Perform other responsibilities as assigned to support our client's company mission.

Key Requirements

Location : Rochester, MN

Contact : Matt Gendelman