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 primary role of this position is to provide support to various quality aspects associated with the processing of radiopharmaceutical isotopes and radiologic science laboratories within the Quality Control team. The role will focus on support activities, such as sampling, general GMP laboratory testing/support, manufacturing operations, and batch release testing of radioactive products. This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.

Duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other regulatory agency standards.

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.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner
• Proficiently operate analytical instrumentation (i.e. scintillation counters, HPGe, ICP-MS, IC). This may also include dose calibrators, survey meters, dosimetry monitors, and wipe test counters.
• Participate in authoring and/or revision of Standard Operating Procedures (SOPs) and forms in the eQMS system.
• Perform incoming inspections of raw materials and components and release in the ERP system.
• Handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform QC functions for ISO 7 and ISO 8 cleanroom cGMP manufacturing operations.

Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline; or equivalent combination of education and experience. Minimum two (2) years of related experience in a cGMP environment and previous experience handling radioactive materials preferred. Understanding of pharmaceutical manufacturing processes, 21 CFR 210/211/820 and familiarity with batch production records (BPR) preferred. Familiarity with alpha, gamma, and beta spectroscopy is a plus.

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.