Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

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, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

The Manager, Quality Control (QC) provides microbiological, chemical, and radiological understanding and oversight for the safe and effective processing of radiopharmaceutical drugs used to diagnose and treat diseases.  The Manager, QC will provide quality control oversight and direction from incoming material inspection and through product release. Projects and duties will be completed in compliance with applicable regulatory agencies standards.

This position supports production in a 24-hour manufacturing facility and may require evenings, nights, weekends, and some holidays with occasional overtime.

• Review and approve documents in support of any quality control testing, batch release testing, and annual stability testing/data performed or generated.
• Hire, manage, and develop QC personnel to ensure compliance with the applicable regulations.
• Provide onsite support during production runs/manufacturing of radioisotopes and final drug product.
• Liaise with Microbiologists and QC personnel at other sites to ensure consistent application of microbiology methods and procedures for GMP laboratory testing.
• Prepare and provide monthly QC quality performance metrics to Senior Management.
• Supervise standard microbiological tasks (e.g. identification of microbial agents, preparation of growth media, growth promotion tests, maintenance of microbial cultures, etc.).
• Familiar with analytical instrumentation used in the Radiation Laboratory.
• Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards of the US FDA, 21 CFR Part 210 & 211.
• Execute internal and external audits as needed.
• Assist in the creation of Standard Operating Procedures, protocols, and reports.
• Develop and validate laboratory procedures within the department and comply with cGMP in all areas of the business.
• Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations. Perform risk assessments, participate in root cause analysis investigations, tracking, follow-up, and reporting/trending.
• Supervise environmental monitoring of ISO-controlled spaces in accordance with all applicable standards.
• Familiar with the use of standard microbiology laboratory equipment.
• Familiar with Bioburden, Sterility, and Bacterial Endotoxin Test (BET) analyses for process samples, including radioactive samples.
• Serve as the subject matter expert in certain areas of Quality Control and analytical instrumentation.
• Maintain and update laboratory databases to track and trend data.
• Provide on-the-floor QC oversight of manufacturing operations.
• Perform other quality functions as necessary, with appropriate training.

Bachelor’s Degree in a scientific discipline and minimum six (6) years of Quality experience in the pharmaceutical, radiopharmaceutical, and/or medical device industry with a minimum two (2) years of management experience; or equivalent combination of education and experience.

Additional required experience includes:

• Managing audits by regulatory agencies and customers.
• Interacting directly with regulatory agencies and customers.
• Responsibility for managing financials for function or area of responsibility.

Knowledge of regulations/standards/guidance (specifically 21 CFR 210 & 211, ICH Q7, Q8, Q9, and Q10) and American Society of Quality (ASQ) certification preferred.

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.

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

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.