Senior Radiopharmaceutical Manufacturing Specialist (1st shift)

NorthStar Medical Radioisotopes•Beloit, WI

5d•Onsite

About The Position

Join the best radiopharmaceutical company in the world! If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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. At the forefront of NorthStar’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 Senior Radiopharmaceutical Manufacturing Specialist performs duties to support manufacturing of radiopharmaceuticals for NorthStar 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. Success in this role requires comfort with repetitive processes, structured schedules, and engagement in a production setting.

Requirements

Associate’s Degree (AS) in a STEM discipline and minimum four (4) years of cGMP experience; or equivalent combination of education and experience. Relevant military experience will also be considered.
Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.

Nice To Haves

Bachelor’s Degree (BS) in a STEM discipline and minimum four (4) years of cGMP experience preferred. CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.

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 NorthStar’s QMS guidelines.
Perform safety checks and routine inspection of the processing equipment and control systems, consumables, and cleanrooms 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 NorthStar’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, 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. Communicate any abnormalities to the leader.