Senior Microbiologist, Product Development

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 Senior Microbiologist, Product Development will be a technical leader, bringing the science of microbiology in a pharmaceutical application to the development and maintenance of equipment, cleanrooms, and processes used in the manufacture of radioisotopes. This includes gathering technical information about engineering system/set up and managing the implementation of novel radioisotope manufacturing technologies. The Senior QAPD Microbiologist will develop and execute microbiological methods and validations from concept phase through design, planning, and execution, as well as coordinating with other departments.

This person is also responsible for working with cross functional teams, including RA/QA and Engineering, to apply efficient cGMP processes, to preserve data integrity and quality of the drug product, and to ensure the safety of all production and non-production personnel.

Responsibilities

• Drive the development of overall microbial validation strategy for pharmaceutical application to development of equipment used in the delivery of radioisotopes. This would include developing and executing methods and validations from concept phase through design, planning, and execution as well as coaching other team members.
• Assist lab management. Be the primary point of contact for microbiology laboratory supplies, instrumentation, and environmental monitoring program activities.
• Develop, plan, implement, and support microbiological development projects in collaboration with cross-functional teams with an overall focus on microbiological safety.
• Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards of the US FDA, 21 CFR Part 210 & 211
• Follow good laboratory practice, good documentation, and good manufacturing practice when creating and executing advanced protocols to verify and/or validate product conformance in the area of microbiological testing and control.

Early Development

After 3 months:

1. You will have completed all required training for new employees; for job-specific duties, and safety; and for access to restricted areas relevant to your job duties.
2. You will have integrated into the quality unit, project, operations, and other cross-functional teams.
3. You will understand the function and responsibilities of each group within other areas of the Quality department.

After 6 months:

1. You will understand the Quality Management Processes that support Aseptic Process Controls, Environmental Monitoring, and other contamination control strategies.
2. You will have become qualified to train, qualify, and maintain operator status in all aspects of Aseptic Process Controls including: Aseptic Techniques, Aseptic Gowning, and Aseptic Process Operator Qualification.
3. You will have engaged a cross-functional team to qualify, and maintain the qualification status of the systems in-place to maintain room classifications, (ISO 5, ISO 7, and ISO 8).

Qualifications

Master's Degree in biological science and five (5) or more years of experience in the pharmaceutical/medical device industry or equivalent combination of education and experience. Experience developing clear, concise, and adequate protocols, procedures, and work instructions required. Must possess a working knowledge of lab controls and general scientific equipment and should strictly adhere to written procedures and enforce it in others. Master's degree in microbiology preferred. Experience with Radiopharmaceuticals would be a strong asset in this position.

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.

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

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.

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.