NorthStar Medical Radioisotopes logo

Radiopharmaceutical Manufacturing Associate (1st shift)

NorthStar Medical Radioisotopes

Beloit, WIOnsitePosted 52 days ago$26.00/hour
Full TimeEntry LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

The Radiopharmaceutical Manufacturing Associate performs duties to support manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards. Success in this role requires comfort with repetitive processes, structured schedules, and engagement in a production setting.

Job description

Position

The Radiopharmaceutical Manufacturing Associate performs duties to support manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards. Success in this role requires comfort with repetitive processes, structured schedules, and engagement in a production setting.

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

After 3 months, you will: 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, you will: 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, positioning yourself as a key player in an innovative and impactful field.

Requirements

  • Associate’s Degree (AS) in a STEM discipline; or equivalent combination of education and experience.
  • Relevant military experience will also 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.

Benefits

  • Medical, Dental & Vision
  • Healthcare FSA
  • Dependent Care FSA
  • Short-term Disability
  • Long-term Disability
  • Life Insurance & AD&D
  • Pet Insurance
  • 401(k) Match
  • Paid Holidays
  • Paid Time Off
  • 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.

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