Manufacturing Supervisor - 2nd Shift
NorthStar Medical Radioisotopes LLC
Supervisor, Radiopharmaceutical Manufacturing 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, NorthStar Medical Radioisotopes is the place to do it. NorthStar 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 NorthStar'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 missionadvancing 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 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 include: 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. After 3 months, you will: Demonstrate a strong understanding of foundational cGMP requirements and just-in-time 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 isotope-specific safety protocols, enabling you to model best practices and reinforce a strong safety culture. Build effective working relationships with cross-functional partnersincluding Quality, Science, and Engineeringto support operational coordination and ensure timely, compliant delivery of radiopharmaceutical products. Gain expertise with NorthStar's 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 cutting-edge manufacturing operations. Fully integrate into NorthStar's mission to transform oncology care, actively supporting a high-performing team that enables global access to innovative radiopharmaceutical therapies. Qualifications include: Associate's 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 includes: Second shift hours are Monday through Thursday 1pm 11:30pm. During this position's training period (approximately 60 days), the ability to work alternate shifts is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility. Working occasional overtime, weekends, and holidays is required. Benefits include: 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 may involve: 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 is: 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 you're 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! NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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