Radiopharmaceutical Manufacturing Specialist; 2nd Shift

Radiopharmaceutical Manufacturing Specialist (2nd Shift)

Join to apply for the Radiopharmaceutical Manufacturing Specialist (2nd Shift) role at North Star Medical Radioisotopes, LLC.

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, North Star Medical Radioisotopes is the place to do it. North Star 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 North Star’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 Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for North Star 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.

Responsibilities

• Execute various aspects of radiopharmaceutical manufacturing, including pre‑production set‑up, manufacturing processes, post‑production activities, and waste stream management.
• Assist in the accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
• Review production Work Orders on the production schedule.
• Author, review, and revise cGMP documentation, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding North Star’s QMS guidelines.
• Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and clean rooms to ensure compliant manufacturing. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
• Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
• Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with North Star’s respective policies and procedures.
• Work cross‑functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects 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 North Star’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.

Quali…