Senior Manufacturing Specialist, Cdmo/Cmo

Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.

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, and customized radiopharmaceutical development services.

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

The Senior Manufacturing Specialist, CDMO/CMO performs duties to support the development and manufacturing of various radioisotopes for NorthStar CDMO/CMO operations. This includes equipment preparation, batch/product synthesis, and aliquoting of finished patient doses while complying with procedures, instructions, and prescribed routines. All projects and duties will be completed in compliance with applicable regulatory agencies, such as DOT, WI DHS, OSHA, cGMP, and FDA.  

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, weekend, and some holiday work will be required with occasional overtime.

• Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical production including but not limited to the manufacturing of the intermediate and finished dose production processes, including pre-production setup, manufacturing processes, post-production activities, and waste stream management.
• Mentor and train new operations personnel on all safety, quality, and production systems.
• Assist in the accurate and timely preparation and completion of records related to production, including Batch Records, Forms, Logbooks, etc.
• Plan and organize production work orders on the production schedule in collaboration with the manager.
• Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Work Instructions (WI), and Production Checklists while upholding NorthStar's QMS guidelines.
• Perform routine inspection of the production equipment and control systems, consumables, safety checks, and cleanrooms to ensure compliant manufacturing.  Notify manager of equipment or operating problems and the need for additional material, supplies or investigations.

Associates or Technical Degree in Science, Technology, Engineering with a minimum of three (3) years of experience in radiopharmaceuticals, pharmaceuticals, or biologics, with knowledge of cGMP and FDA requirements; or equivalent combination of education and experience.  Strong mechanical aptitude and some scientific background is required.

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.

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location 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.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. 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.