Radiopharmaceutical Manufacturing Associate

Key Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, and post-production activities.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Perform safety checks and routine inspection of the processing equipment, consumables, and cleanrooms to ensure effective production. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• Receive and track inventory of materials, consumables, and equipment list and report any deficiencies to the leader.
• Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Support troubleshooting of manufacturing equipment and process issues, and escalating manufacturing, safety, and compliance issues.
• Support interdepartmental activities including production scale-up and continuous process improvement.

Early Development Milestones

• After 3 months:
• Understand foundational cGMP and just-in-time radiopharmaceutical manufacturing principles.
• Become a qualified Radiation Worker, trained in ALARA principles and isotope-specific safety protocols.
• Collaborate effectively with cross-functional teams, including Quality, Science, and Engineering, to ensure timely delivery of radiopharmaceuticals for cancer treatment.
• Gain hands-on experience with state-of-the-art manufacturing technology under expert supervision.
• After 6 months:
• Achieve Qualified Operator status with demonstrated competency to execute full batch manufacturing of novel isotopes.
• 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.

Qualifications

• Associate’s Degree (AS) in a STEM discipline; or equivalent combination of education and experience.
• Relevant military experience will be considered.
• Bachelor's Degree in a STEM discipline and minimum one year (1) of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience preferred.

Shift Information

• 2nd shift (CDMO): Monday through Friday, 2pm - 10:30pm.
• During training (approx. 60 days), candidates must be able to work alternate shifts.
• These roles support production in a 24-hour manufacturing facility, Monday through Friday, with occasional overtime and holiday coverage required.
• Eligible for an additional $5.00/hour shift premium for hours worked between 6:00pm and 6:00am.

Working Conditions

• May involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas.
• Exposure to varying temperatures, both indoors and outdoors.
• Noise levels range from quiet to loud.
• Specific vision abilities required: 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, and nail products.
• As a radiopharmaceutical manufacturing site, radiation may be present. Employees may be required to:
• Follow strict radiation safety procedures.
• Participate in dosimetry monitoring and bioassay testing.
• Inform leadership of any health conditions that may affect product integrity.

Location

• Beloit, Wisconsin.

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.
• Relocation benefit.