About this role
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. Join to make an impact while building a meaningful career in a specialized, fast-growing field. Our work uses first-in-kind electron accelerator technology and integrated campus capabilities.
The Radiopharmaceutical Manufacturing Specialist performs duties to support manufacturing of radiopharmaceuticals, including equipment preparation, product dissolution, and dispensing of medical radioisotopes. All duties comply with procedures, instructions, prescribed routines, and applicable regulatory agency standards. Success requires comfort with repetitive processes, structured schedules, and engagement in a production setting.
Work cross-functionally with Quality, Science, and Engineering teams in world-class facilities. Maintain cleanrooms, equipment, and materials per NorthStar policies. Contribute to interdepartmental projects including production scale-up and continuous process improvement.
After 3 months, understand foundational cGMP and just-in-time radiopharmaceutical manufacturing principles, become a qualified Radiation Worker trained in ALARA and isotope-specific safety. After 6 months, achieve Qualified Operator status to execute full batch manufacturing of novel isotopes. Gain hands-on experience with state-of-the-art technology under expert supervision.
Requirements
- Comfort with repetitive processes, structured schedules, and production settings
- Ability to comply with cGMP procedures, instructions, and regulatory standards
- Familiarity with radiopharmaceutical manufacturing equipment preparation and dispensing
- Knowledge of cleanroom maintenance and waste stream management
- Proficiency in completing Batch Records, Logbooks, and other manufacturing documentation
- Understanding of ALARA principles and radiation safety protocols
- Skill in performing equipment inspections and inventory management
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 manufacturing records, including Batch Records, Forms, Logbooks
- Review production Work Orders on the production schedule
- Author, review, and revise cGMP documentations, such as Batch Production Records, Standard Operating Procedures, Work Instructions, and Production Checklists
- Perform safety checks and routine inspections of production processing equipment, control systems, consumables, and cleanrooms
- Maintain accurate inventory of materials and consumables, and coordinate equipment traceability
- Maintain the cleanliness and orderliness of the cleanroom and manufacturing spaces, equipment, and materials
- Work cross-functionally on standardized root cause analysis, investigation tools, and methodologies
Benefits
- Exceptional career growth and professional development opportunities
- World-class facilities and state-of-the-art manufacturing technology
- Training to become qualified Radiation Worker and Operator
- Cross-functional collaboration with Quality, Science, and Engineering teams
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