MSAT II, CDMO

NorthStar Medical Radioisotopes • Beloit, WI

4d • Onsite

About The Position

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

The position supports manufacturing in a range of environments, potentially including controlled cleanrooms, offices, and manufacturing areas. Work may involve temperature variation, noise, required PPE, cleanroom gowning, and radiation safety procedures, including dosimetry monitoring and bioassay testing. The position is based at NorthStar Medical Radioisotopes’ headquarters and primary manufacturing facility in Beloit, Wisconsin.

Requirements

• Bachelor’s degree in a relevant STEM field and relevant technical experience in a regulated industry and/or medical or pharmaceutical manufacturing environment, or an equivalent combination of education and experience.
• The posting states a minimum of “six (3) years” of relevant technical experience in technology transfer, product development, process validation, or commercial manufacturing; the stated number is inconsistent.
• Knowledge of Lean manufacturing, continuous improvement methodologies, and operational excellence principles.
• Comply with cleanroom gowning protocols, including removing jewelry, and refrain from cosmetics, fragrances, and nail products in applicable areas.
• Use required personal protective equipment, which may include respirators, gloves, safety glasses, and full protective clothing.
• Follow strict radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required.

Nice To Haves

• Experience supporting manufacturing programs within a CDMO, biopharmaceutical, biotechnology, or pharmaceutical environment.
• Working knowledge of regulatory requirements and industry guidance, including experience supporting sponsor audits and regulatory inspections.
• Experience with radiopharmaceutical process development, upstream processing, downstream processing, or fill-finish operations.
• Lean Six Sigma Green Belt certification or higher.

Responsibilities

• 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 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 improve process robustness and operational efficiency.
• Lead investigations involving 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 for technical accuracy and compliance.
• Coordinate cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other groups to support manufacturing needs.
• Lead process characterization studies, validation activities, continued process verification, and commercial readiness activities.
• Manage technical workstreams, establish priorities, and ensure project deliverables meet business and sponsor needs within established timelines.
• Lead continuous improvement initiatives using Lean, root cause analysis, and operational excellence methodologies.
• Develop training programs and train Operations staff on manufacturing processes and equipment.
• Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
• Perform duties in compliance with safety and regulatory standards, including cGMP/FDA, OSHA, DOT, and Wisconsin DHS requirements.
• Follow radiation safety procedures and participate in dosimetry monitoring and bioassay testing as required.
• Inform leadership of health conditions that may affect product integrity under cleanroom standards.

Benefits

• Medical, dental, and vision insurance.
• Healthcare Flexible Spending Account (FSA) and Dependent Care FSA.
• Company-paid short-term and long-term disability.
• Company-paid life insurance and AD&D coverage.
• Pet insurance.
• 401(k) match.
• Paid holidays and paid time off (PTO).
• Paid parental leave.
• Bonus plan.
• Equity Incentive Program.
• Competitive benefits package.
• Career growth and professional development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level