Senior MSAT, 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 Senior MSAT, CDMO role serves as a technical leader and subject matter expert responsible for complex technology transfer, process validation, scale-up, and commercial manufacturing. This role provides strategic technical direction, leads high-impact investigations and improvement efforts, and represents the organization during sponsor or regulatory interactions, audits, etc. The position influences organizational capability through technical mentorship, cross-functional leadership, and the advancement of manufacturing excellence across multiple programs.

• Serve as a technical lead for technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide strong technical oversight to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Establish and maintain standards for technical documentation including protocols, reports, batch records, and process descriptions.
• Conduct advanced technical evaluations of process performance, identify systemic improvement opportunities, and recommend long-term optimization strategies 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.
• Build alignment amongst cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Provide guidance and technical leadership for process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Act as the primary SME during sponsor or regulatory interactions, audits, or inspections.
• Manage complex technical projects, managing risks, priorities, schedules, and technical deliverables to achieve business objectives.
• Mentor and develop other MSAT team members by providing technical coaching, knowledge transfer, and development guidance while influencing organizational capability without direct authority.
• 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:

• Expand expertise in process characterization, validation strategy, and advanced risk assessments
• Serve as the primary representative during sponsor or regulatory interactions, audits, or inspections
• Mentor MSAT team members and influence best practices within the CDMO organization

After 6 months, you will:

• Develop recognized subject matter expertise in manufacturing principles
• Influence strategic approaches and product life cycles across multiple programs
• Establish and implement long-term continuous improvement roadmaps that support operational excellence and commercial growth

MINIMUM…