MSAT II, CDMO

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, North Star Medical Radioisotopes is the place to do it. North Star Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of North Star’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

The MSAT II, CDMO role independently leads technical activities supporting technology transfer, process validation, scale-up, and commercial manufacturing activities within a CDMO environment. This role serves as a primary technical resource for manufacturing operations, investigations, process monitoring, and cross-functional project execution. The position drives process improvements, manages technical deliverables, and regularly interfaces with sponsors and internal stakeholders to ensure successful program outcomes.

• Lead technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide technical support to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Generate, update, and review technical documentation including protocols, reports, batch records, and process descriptions.
• Collect and analyze manufacturing performance data, identify trends, and develop data driven recommendations to improvements process robustness and operational efficiency.
• Lead investigations including deviations, non-conformances, manufacturing events, and out-of-specification results by gathering data and performing risk assessments or root cause analysis.
• Contribute to and review change controls, CAPAs, and quality system records to ensure technical accuracy and compliance.
• Coordinate cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Lead process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Manage technical work streams, establish priorities, and ensure project deliverables meet business and sponsor needs per established project timelines.
• Lead continuous improvement initiatives utilizing Lean, root cause analysis, and operational excellence methodologies.
• Develop training programs and provide training to Operations on manufacturing processes and equipment.
• Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
• Perform all duties and responsibilities in compliance with safety and regulatory standards (e.g., cGMP/FDA, OSHA, DOT, WI DHS, etc.).

After 3 months, you will:

• Lead a technology transfer, process validation, or manufacturing support project with cross-functional coordination
• Conduct technical assessments and provide recommendations for process improvements
• Strengthen sponsor communication and presentation skills through sponsor interactions

After 6 months, you…