About the role
Overview
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 mission—advancing 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.
Position
The Senior Accelerator Operator will assist in the development of the processes around routine and non-routine particle (electron) accelerator equipment operations and maintenance tasks necessary to safely, compliantly, and efficiently manufacture radiopharmaceuticals. The Senior Accelerator Operator will guide a team of operators in performing routine and abnormal operations, maintenance and training. This position will lead installation, commissioning, maintenance and operation activities associated with Accelerators and their support systems. The Senior Accelerator Operator will be highly involved in development and improvement of related procedures and operating guidance. This position requires working closely with a highly trained operational team and other engineering focused departments. The individual will be required for the operational success of the radioisotope production process, including accelerator startup/shutdown operations and maintenance, target irradiation, and other routine operations.
This position will be the point of contact to a shift team that must work independently and with limited supervision. The shift team will be responsible for responding to abnormal incidents and breakdowns, escalating issues appropriately, and troubleshooting as necessary.
Responsibilities
- Safely, compliantly, and efficiently operates the accelerators and associated systems and equipment, such as hot cells, primary cooling systems, and development work on filling and packaging lines
- Provide support for operational and testing activities of the accelerator and associated systems.
- Give direction and perform routine maintenance, functional tests, and inspections of accelerators and associated systems, and equipment.
- Lead the development of production documents, such as Standard Operating Procedures, Work Instructions, Forms, and Logs.
- Lead the performance of engineering design and validation testing.
- Lead a team in the performance of advanced troubleshooting to include accelerator control systems, vacuum systems and accelerator associated support systems.
- Work closely with and coordinate with accelerator support departments to ensure operational readiness is maintained at all times.
- Perform various aspects of the radiopharmaceutical irradiation and production process, including pre-production set-up, manufacturing processes, and post-production activities.
- Give direction and assist as needed in performing various aspects of the radiopharmaceutical production process, including pre-production set-up, manufacturing processes, and post-production activities.
- Assist in the accurate and timely preparation and completion of records related to radiopharmaceutical irradiation and production, including Batch Records, Forms, Log Books, etc.
- Give direction and assist as needed to maintain the cleanliness and orderliness of the facility, equipment, and materials, per NorthStar’s respective policies and procedures.
- Strictly adhere to quality, safety, regulatory, and written procedures in the manufacture of products: accordance with NorthStar’s Quality System and Health & Safety Program, relevant State and Federal regulations, and guidelines.
- Lead 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.
- Performs proactively, collaboratively, and with the flexibility to ensure 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:
- Obtain Radiation Worker Qualification, demonstrating a strong understanding of ALARA principles, regulatory requirements, industrial safety standards and modeling these expectations for the team.
- Develop a thorough understanding of daily operational workflows, enabling you to guide and support staff in meeting production priorities and ensuring the timely, compliant delivery of radiopharmaceuticals for patient treatment.
- Transition into a designated shift leadership role, overseeing routine activities with minimal oversight, ensuring procedural compliance and maintaining a safe, efficient and well-coordinated work environment.
- Gain supervisory familiarity with advanced manufacturing technologies, observing processes under expert guidance to further prepare for overseeing team performance and troubleshooting operational challenges.
Within 6-9 months, you will:
- Achieve full qualification and demonstrate supervisory competency in at least one irradiation or production process, enabling you to provide direction, coaching and performance feedback to team members.
- Drive Operational Excellence using KPIs and performance metrics to identify opportunities for process improvement, elevate team effectiveness and uphold production quality standards.
- Fully embody and champion NorthStar's mission, fostering a culture of accountability, innovation and patient-centered purpose as we advance global access to breakthrough radiopharmaceuticals.
Qualifications
MINIMUM EDUCATION/EXPERIENCE
Associate or Technical Degree in a STEM discipline and minimum six (6) years working within a highly regulated environment, cGMP preferred; or equivalent combination of education and experience. Strong mechanical aptitude is required. Experience working with electronics, test equipment, and/or mechanical systems is required. Advanced troubleshooting experience is preferred.
PREFERRED EDUCATION/EXPERIENCE
Bachelor’s Degree in science, technology, physics, or engineering with minimum six (6) years experience within a highly regulated environment, cGMP preferred. Working knowledge and experience of the operation of an accelerator, nuclear reactor, or other radiation-producing devices. Advanced troubleshooting experience is preferred. Relevant military experience will also be considered.
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
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 – 6:15PM and Night shift is 6:00PM – 6:15AM. Evenings, nights, weekends and some holidays will be required with scheduled overtime every other week.
Benefits
Medical, dental, and vision insurance
Healthcare Flex Spending Account (FSA) and Dependent Care FSA
Company-paid short-term and long