Overview

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.

Position

The MS&T Process Specialist is responsible for supporting both internal and external technical transfer activities to support manufacturing readiness. This includes assisting in the writing and development of GMP batch records, methods, and other necessary documentation to ensure effective process transfer between process development and operations. This position will assist with writing and updating SOPs and technical documents pertaining to GMP operations, and providing technical input for deviation investigations, change controls, and CAPAs.

All duties and responsibilities will be done in compliance with cGMP and FDA regulations.

Responsibilities

• Work cross-functionally with other departments to effectively transfer and maintain processes in the facility.
• Assist in developing/executing design transfer plans for new products and maintain batch production records and process documentation for new and existing programs.
• Assist in improving/optimizing manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals.
• Assist in preparing and executing cGMP procedures, protocols, reports, and plans for chemical/fluid, filling, hot cells, and packaging processes in pharmaceutical clean room environments.
• Keep equipment operational by coordinating maintenance and repair services following manufacturer's instructions and established procedures.
• Assist in developing training programs and provide training on process systems and equipment.
• Support the investigation of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.

Qualifications

Bachelor’s Degree in applicable scientific field such as chemistry, biology, or biochemistry; or equivalent combination of education and experience and 1 year of experience in a cGMP manufacturing environment.

Please note that U.S. Immigration sponsorship or work visa is not available for this position and candidates must have permanent authorization to work in the U.S.

Location

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.