Overview

The Supervisor, Radiopharmaceutical Manufacturing will be responsible for leading daily production activities, ensuring compliance with all regulatory standards, safety standards, and company policies. This role is responsible for delivering all types of batches, including but not limited to clinical and commercial client batches per schedule and contract obligations. This position will lead and mentor a team, efficiently allocate resources, and continuously seek to enhance production processes to optimize operational efficiency. This position plays a key role in maintaining the integrity and safety of the manufacturing environment which is essential for the successful delivery of clinical and commercial radiopharmaceutical products.

Responsibilities

• Manage the day-to-day activities and personnel to ensure efficient manufacturing of products to meet the master production schedule ensuring compliance with regulatory requirements, while maintaining high safety standards.
• Provide leadership, training, and support to the team. Responsible for the performance of team members and ensuring training requirements are achieved.
• Monitor and enforce strict quality assurance procedures and key operational metrics to meet the specifications of each product.
• Address and resolve any issues related to equipment, processes, or personnel in a timely and effective manner with proper communication and/or escalation as needed.
• Effectively communicate with essential manufacturing support groups to ensure clarity on product specifications, address any escalations promptly, and coordinate delivery schedules. Regularly update management on production status and any critical issues.
• Responsible to ensure complete and accurate records are maintained for Radiopharmaceutical Manufacturing (Batch Production Record) according to customer and/or Product Development orders.
• Assist leader in maintaining the department’s budget, focusing on the efficient allocation and utilization of resources by monitoring monthly production expenditures.
• Collaborate with the manufacturing support teams to allocate resources effectively, supporting the technology transfer and process scale-ups in radiopharmaceutical manufacturing to meet business needs and product development goals.

Early Development

After 3 months, you will:

• Demonstrate a strong understanding of foundational cGMP requirements and just0in0time radiopharmaceutical manufacturing principles, with the ability to guide team members in applying them consistently.
• Obtain qualification as a Radiation Worker, including training in ALARA principles and isotope0specific safety protocols, enabling you to model best practices and reinforce a strong safety culture.
• Build effective working relationships with cross0functional partners00including Quality, Science, and Engineering00to support operational coordination and ensure timely, compliant delivery of radiopharmaceutical products.
• Gain expertise with NorthStar0s advanced manufacturing systems and processes, preparing you to oversee daily operations and support the development of technical staff.

After 6 months, you will:

• Contribute to Operational Excellence by managing team performance against key KPIs and implementing process improvements that enhance production efficiency, safety, and product quality.
• Achieve Qualified Operator status and obtain qualifications as a licensed Authorized User, with the capability to oversee and support the team in executing full batch manufacturing of novel isotopes while ensuring adherence to defined regulatory standards and procedures.
• Develop and lead a high performing organization, positioning yourself as a key leader who drives team capability, fosters continuous improvement, and supports the growth of cutting0edge manufacturing operations.
• Fully integrate into NorthStar0s mission to transform oncology care, actively supporting a high0performing team that enables global access to innovative radiopharmaceutical therapies.

Qualifications

Associate0s Degree (AS) in a STEM discipline and minimum four (4) years of cGMP experience; or equivalent combination of education and experience. Minimum one (1) year of experience leading others required.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.

Shift Information

2nd shift (CDMO): Second shift hours are Monday through Friday, 2pm - 10:30pm. During this position0s training period (approximately 60 days), candidates must be able to work an alternate shift at least once. Primary shift placement will occur upon successful completion of the training program. These roles support production in a 24-hour manufacturing facility, Monday through Friday, with occasional overtime and holiday coverage required.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex 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

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you0re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.

Please note that this position is eligible for a lump sum relocation benefit!