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
- Ph.D. in Radiochemistry, Chemistry, or other related science required.
- Minimum 5 years of relevant experience which should include extensive hands-on work labeling small molecules, peptides, and/or antibodies with a variety of therapeutic alpha- and beta-emitting radioisotopes required.
- Prior experience with direct reports required.
- Experience in preparing CMC documentation for regulatory submissions (e.g., IND, NDA).
- Familiarity with GMP environments and radiopharmaceutical manufacturing processes.
- Proven track record of successful client engagements and project delivery in a fast-paced, innovative setting.
- Technical Proficiency: Advanced ability to design, analyze, and interpret complex data sets using logical, statistical, and mathematical methodologies.
- Problem-Solving: Demonstrated ability to proactively identify issues, prioritize tasks, and implement effective solutions in a dynamic environment.
- Leadership and Collaboration: Exceptional interpersonal and communication skills, with a proven ability to lead teams, foster collaboration, and build strong working relationships.
- Independent Work Ethic: Capacity to work autonomously, manage multiple priorities, and deliver high-quality results within tight deadlines.
- Attention to Detail: Highly organized with a commitment to precision, quality, and compliance in all aspects of work.
- Adaptability: Willingness to work extended hours or weekends as needed to meet project demands.
- Innovation Mindset: Passion for exploring novel technologies and methodologies to advance radiopharmaceutical development.
Location: Rochester, MN
Contact: Matt Gendelman