Senior Manufacturing Specialist - NorthStar Medical Radioisotopes

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 performs equipment preparation, product dissolution, and dispensing of medical radioisotopes 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) in the various aspects of the medical radioisotope production process, including pre-production set-up, 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 medical radioisotope production, including digital Batch Records, Forms, Log Books, etc.
• Participate in internal and external compliance audits and assist with auditor interactions as needed.
• Assist with operations shift management and scheduling as needed under Supervisor direction.
• Plan and organize production Work Orders using a dedicated Enterprise Resource Planning software in collaboration with the Supervisor.
• 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.

High School diploma and four (4) years of experience in a cGMP or other regulated production environment.  Strong mechanical aptitude and some scientific background are 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.