Senior Radiopharmaceutical Manufacturing Specialist; 3rd Shift
Listed on 2026-06-18
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Manufacturing / Production
Pharmaceutical Manufacturing, Quality Engineering, Validation Engineer, Manufacturing Engineer
Join to apply for the Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift) role at North Star Medical Radioisotopes, LLC
Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift)3 days ago Be among the first 25 applicants
Join to apply for the Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift) role at North Star Medical Radioisotopes, LLC
Overview
Accelerate your career with North Star!
North Star Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner. We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.
At North Star, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities.
Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. North Star offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all North Star employees are eligible on day one for our annual bonus and equity incentive plans.
Position
The Senior Radiopharmaceutical Manufacturing Specialist performs duties to support the development and manufacturing of radiopharmaceuticals for North Star operations. This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
Responsibilities
- Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing including but not limited to the manufacturing of the intermediate and finished dose production processes. This includes pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
- Mentor and train new manufacturing personnel on all safety, quality, and production systems.
- Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
- Participate in internal and external compliance audits and assist with auditor interactions as needed.
- Support the business development team in interaction with current and potential sponsors.
- Plan and organize production Work Orders on the production schedule in collaboration with leadership.
- Author, review, and revise cGMP documentations, 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 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 facility, equipment, and materials in accordance with North Star’s respective policies and procedures.
- Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA. Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
- Contribute to interdepartmental projects including production scale-up,…
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