Quality Control Lead

Overview

Join the best radiopharmaceutical company in the world!

If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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.


At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission-advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

Position

The primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards. This role requires extensive training on radiation safety including ALARA ("as low as reasonably achievable") principles.

Projects and duties will be completed in compliance with applicable 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, late evening, 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.
• Lead, coordinate, and communicate QC Team responsibilities and activities.
• Provide on the job training for QC team and assist in trouble shooting analytical instruments.
• Proficiently operate analytical instrumentation.
• Perform company-wide training and facilitate training program for QC personnel on industry best practices for ISO controlled environments.
• Author, review, and approve quality test data, protocols, reports, SOPs.
• Assist with the transfer of validation activities of Quality Control (QC) test methods.
• Serve as the subject matter expert in analytical instrumentation.
• Participate independently as the lead on multiple projects and meetings.
• Support the department manager and/or designee in their absence.
• 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.
• Participate in internal assessments and regulatory audits as required.

Early Development

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Provide support to site operational readiness
• Start training on final product testing and batch processes

After 6 months you will:

• Be qualified on more advanced analytical techniques such as HPLC
• Be proficient in the majority of QC batch release activities
• Support tech transfer, stability, and product validation testing
• Be qualified to provide training to other team members on certain QC functions

Qualifications

Bachelor's Degree in Chemistry, Biology, or other related scientific discipline and minimum nine (9) years of experience in a regulated industry; or equivalent combination of education and experience. Preferred qualifications include:

• Nine (9) years of related experience in a cGMP environment and previous experience handling radioactive materials preferred.
• Understanding of pharmaceutical manufacturing processes.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

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.

Shift Information

1st Shift: 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, late evening, weekend, and some holiday work will be required with occasional overtime.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

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

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site , radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.

Please note that this position is eligible for a lump sum relocation benefit!

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.