Nuclear Pharmacist
3 weeks ago
We are seeking a highly skilled Nuclear Pharmacist to join our team at NorthStar Medical Radioisotopes LLC. As a Nuclear Pharmacist, you will play a critical role in the manufacturing of radiopharmaceuticals for clinical trials and commercial products.
Key Responsibilities:- Operate as the Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing, including the manufacturing of drug intermediates and finished dose production processes.
- Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
- Demonstrate expert knowledge of radiopharmaceutical compounding and dispensing procedures by staying current with drug manufacturing regulations and requirements.
- Mentor and train new manufacturing personnel on all safety, quality, and production systems, including aseptic handling practices.
- Independently use, calibrate, and maintain all instrumentation required for radiopharmaceutical manufacturing operations.
- 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 NorthStar's QMS guidelines.
- Perform safety checks and routine inspection of the processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing.
- 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 NorthStar's respective policies and procedures.
- Engage in completion of all workflows inside QMS, including deviations, OOSs, change controls, document changes (DCO), and CAPA.
- Contribute to interdepartmental projects, including production scale-up, product development, continuous process improvement, which includes qualification and validation activities.
- Work with Facilities and Maintenance group on preventative maintenance (PM) review and troubleshooting implementation plan, and assist in tracking scheduled system maintenance and equipment calibrations while keeping an open line of communication.
- Monitor product quality to ensure compliance with standards and specifications by identifying and verifying appropriate materials, area conditions, and process for production.
- PharmD or similar training and minimum two (2) years of experience in practicing nuclear pharmacy procedures.
- Board Certified Nuclear Pharmacist (BCNP) credential is preferred.
- Previous experience in a good manufacturing practices (cGMP) setting is preferred.
- Must maintain an active pharmacist license.
- Authorized User of radioactive materials certification is required.
NorthStar Medical Radioisotopes LLC is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company-provided dosimetry and bioassay testing.
Beloit, Wisconsin, is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
We are an equal opportunity employer and welcome applications from diverse candidates. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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