Supervisor, Radiopharmaceutical Manufacturing
: Job Details :

Overview:

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

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, and customized radiopharmaceutical development services.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position:

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.

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, weekend, and some holiday work will be required.

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders.

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

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 departments 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.

Qualifications:

Associates 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.

Location:

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

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.