Accelerator Operator (Days)
NorthStar Medical Radioisotopes
Summary
The Accelerator Operator is responsible for performing routine and non-routine particle (electron) accelerator equipment operations and maintenance tasks necessary to safely, compliantly and efficiently manufacture bulk radiopharmaceuticals. This position will assist with the installation, commissioning, maintenance and operation of accelerator systems and associated equipment, and the development of associated process procedures and instructions.
Job description
Responsibilities
- Safely, compliantly, and efficiently operate the accelerators and associated systems and equipment, such as hot cells, primary cooling systems, and development work on filling and packaging lines.
- Perform operational and testing activities of the accelerator and associated systems.
- Perform routine maintenance, functional tests, and inspections of accelerators and associated systems and equipment.
- Conduct performance of engineering design and validation testing.
- Perform advanced troubleshooting to include accelerator control systems, vacuum systems and accelerator associated support systems.
- Develop production documents, such as Standard Operating Procedures, Work Instructions, Forms, and Logs.
- Perform various aspects of the radiopharmaceutical irradiation and production process, including pre-production set-up, manufacturing processes, and post-production activities.
- Accurate and timely preparation and completion of records related to radiopharmaceutical irradiation and production, including Batch Records, Forms, Log Books, etc.
- Maintain the cleanliness and orderliness of the facility, equipment, and materials, per NorthStar’s respective policies and procedures.
- Provide front-line troubleshooting of manufacturing equipment and process issues, and escalating manufacturing, safety, and compliance issues observed to staff in a timely and appropriate manner.
- Perform assigned tasks proactively, collaboratively, and with flexibility ensuring the team can safely, compliantly, and efficiently meet or exceed the needs of the business and customers.
Early Development
Within 3-6 months, you will: Become a qualified Radiation Worker, trained in ALARA principles and industrial safety protocols. Collaborate effectively within operations to support operational priorities and ensure timely delivery of radiopharmaceuticals for cancer treatment. Gain hands-on experience with state-of-the-art manufacturing technology under expert supervision.
Within 6-9 months, you will: Achieve full qualification status with demonstrated competency in at least one irradiation production process. Be assigned to a specific shift and operate under minimal supervision. Contribute to Operational Excellence by maintaining optimum KPIs and metrics to enhance production efficiency and quality. Fully integrate into NorthStar’s mission to revolutionize oncology treatment by providing patients with global access to game-changing radiopharmaceuticals. Develop advanced technical skills in handling sophisticated manufacturing processes and technologies, positioning yourself as a key player in an innovative and impactful field.
Qualifications
MINIMUM EDUCATION/EXPERIENCE: Associates or Technical Degree in a STEM discipline and minimum four (4) years of experience within a highly regulated environment, or equivalent combination of education and experience. Strong mechanical aptitude is required. Relevant military experience will also be considered.
PREFERRED EDUCATION/EXPERIENCE: Bachelor’s Degree in a STEM discipline and minimum four (4) years of experience within a highly regulated or cGMP manufacturing environment; or equivalent combination of education and experience. Working knowledge of the operation of an accelerator, nuclear reactor, or other radiation producing devices and experience in radiopharmaceutical production. Some scientific background is ideal.
Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.
Shift Information
This position supports production in a 24-hour manufacturing facility and works a rotating schedule: Week 1 – Sunday, Tuesday, Wednesday, Thursday Week 2 – Monday, Friday, Saturday Day shift is 6:00AM – 6:00PM and Night shift is 6:00PM – 6:00AM. Evenings, nights, weekends and some holidays will be required with scheduled overtime every other week.
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
Requirements
- Associates or Technical Degree in a STEM discipline
- Minimum four (4) years of experience within a highly regulated environment
- Strong mechanical aptitude
- Relevant military experience will also be considered
- Bachelor’s Degree in a STEM discipline preferred
- Minimum four (4) years of experience within a highly regulated or cGMP manufacturing environment preferred
- Working knowledge of the operation of an accelerator, nuclear reactor, or other radiation producing devices preferred
- Experience in radiopharmaceutical production preferred
- Some scientific background is ideal
Benefits
- Medical, Dental & Vision
- Healthcare FSA
- Dependent Care FSA
- Short-term & Long-term Disability
- Life Insurance & AD&D
- Pet Insurance
- 401(k) Matching
- Paid Holidays & PTO
- Paid Parental Leave
- Bonus Plan
- Equity Incentive Program
- Relocation Benefit
Company overview
NorthStar Medical Radioisotopes, LLC is a commercial-stage nuclear medicine company headquartered in Beloit, Wisconsin, with additional facilities in Madison, Wisconsin. Founded in 2006, the company specializes in developing, producing, and manufacturing reliable and environmentally-friendly diagnostic and therapeutic radiopharmaceuticals. NorthStar's mission is to provide patients global access to game-changing radiopharmaceuticals for cancer detection and treatment. The company is the first and only U.S. company housing commercial-scale radioisotope production and radiopharmaceutical CDMO services co-located on the same campus. NorthStar routinely produces therapeutic radioisotopes including copper-67 (Cu-67) and is poised to be one of the first commercial-scale producers of non-carrier-added actinium-225 (Ac-225) using innovative electron accelerator technology. Their FDA-approved diagnostic imaging product, technetium-99m (Tc-99m), is used in 40,000 patient imaging studies daily in the United States. The company also operates a Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO/CMO) unit that provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies advance their development and commercial programs.