Supervisor, Radiopharmaceutical Manufacturing (2nd Shift)

About the role

NorthStar Medical Radioisotopes is seeking a Supervisor, Radiopharmaceutical Manufacturing to lead daily production activities, ensure compliance with regulatory and safety standards, and mentor a manufacturing team. The role delivers clinical and commercial batches, optimizes operational efficiency, and maintains the integrity and safety of the manufacturing environment.

Responsibilities

• Manage day‑to‑day manufacturing activities and personnel to meet the master production schedule while complying with regulatory requirements and high safety standards.
• Provide leadership, training, and support to the team; ensure performance and training requirements are met.
• Monitor and enforce strict quality‑assurance procedures and key operational metrics to meet product specifications.
• Address and resolve equipment, process, or personnel issues promptly, escalating when necessary.
• Communicate with manufacturing support groups to clarify product specifications, handle escalations, and coordinate delivery schedules.
• Update management regularly on production status and critical issues.
• Maintain complete and accurate Radiopharmaceutical Manufacturing Batch Production Records per customer and product development orders.
• Assist in department budgeting, focusing on efficient allocation and utilization of resources by monitoring monthly production expenditures.
• Collaborate with support teams to allocate resources for technology transfer and process scale‑ups to meet business and product development goals.

Early Development

After 3 months

• Demonstrate strong understanding of foundational cGMP requirements and just‑in‑time radiopharmaceutical manufacturing principles, guiding team members in consistent application.
• Obtain qualification as a Radiation Worker, including ALARA training and isotope‑specific safety protocols, modeling best practices and reinforcing a strong safety culture.
• Build effective working relationships with cross‑functional partners (Quality, Science, Engineering) to support operational coordination and timely, compliant product delivery.
• Gain expertise with NorthStar’s advanced manufacturing systems and processes, preparing to oversee daily operations and support technical staff development.

After 6 months

• Contribute to Operational Excellence by managing team performance against key KPIs and implementing process improvements that enhance efficiency, safety, and product quality.
• Achieve Qualified Operator status and obtain qualifications as a licensed Authorized User, enabling oversight of full batch manufacturing of novel isotopes while ensuring regulatory compliance.
• Develop and lead a high‑performing organization, driving team capability, continuous improvement, and growth of cutting‑edge manufacturing operations.
• Fully integrate into NorthStar’s mission to transform oncology care, supporting a high‑performing team that enables global access to innovative radiopharmaceutical therapies.

Qualifications

• Associate’s Degree (AS) in a STEM discipline (or equivalent combination of education and experience).
• Minimum four (4) years of cGMP experience.
• At least one (1) year of experience leading others.
• Eligibility to complete Form I‑9 and provide proof of identity and employment authorization.
• Company cannot provide immigration‑related sponsorship for this position.

Schedule

2nd shift (CDMO): Monday – Friday, 2 pm – 10:30 pm. During the approximately 60‑day training period, candidates must be able to work an alternate shift at least once. Primary shift placement occurs after successful completion of training. The role supports 24‑hour manufacturing operations with occasional overtime and holiday coverage.

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 & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

• Controlled cleanroom environment, general office setting, and specific manufacturing areas.
• Exposure to varying temperatures (heated/air‑conditioned indoor spaces and outdoors).
• Noise levels ranging from quiet to loud, depending on the work area.
• Specific vision requirements: near vision, visual acuity, and color discrimination.
• Personal Protective Equipment (PPE) required: respirators, gloves, safety glasses, full protective clothing.
• Compliance with cleanroom gowning protocols (no jewelry, cosmetics, fragrances, or nail products).
• Potential radiation exposure; strict radiation safety procedures, dosimetry monitoring, and bioassay testing are required.
• Requirement to inform leadership of any health conditions that may affect product integrity under cleanroom standards.

Location

The position is based in Beloit, Wisconsin, where NorthStar Medical Radioisotopes’ headquarters and primary manufacturing facility are located. Beloit offers a vibrant downtown, cultural events, outdoor recreation, and proximity to Madison, Milwaukee, Chicago, and Rockford. A lump‑sum relocation benefit is available for eligible candidates.