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 t…
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 t…
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 t…
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 t…
Skills: GMP Compliance, GLP Compliance, Quality Assurance, Batch Record Review, Root Cause Analysis
Overview NorthStar Medical Radioisotopes is a growing commercial-stage organization dedicated to advancing patient care through the development and supply of therapeutic radioisotopes and novel radiopharmaceuticals used …
Skills: AI Application Development, Automation, Prompt Engineering, LLMs, Microsoft Power Platform
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 t…
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 t…
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 t…
Skills: Radiopharmaceutical Manufacturing, cGMP, ALARA Principles, Radiation Safety, Cleanroom Protocols
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 t…
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 t…
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 t…
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 t…
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 t…
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 t…
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 t…
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 t…
Skills: Radiopharmaceutical Manufacturing, cGMP, ALARA Principles, Radiation Safety, Cleanroom Protocols
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 t…
Skills: cGMP, Radiopharmaceutical Manufacturing, Team Leadership, Radiation Safety, ALARA Principles
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 p…
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 p…
Skills: cGMP, Radiopharmaceutical Manufacturing, Aseptic Processing, Cleanroom Protocols, ALARA Principles
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 p…
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Full-time
associate degree, bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Healthcare Flex Spending Account (FSA), Dependent Care FSA, Short-term Disability
Posted 4d ago
Apply by Jul 23
~32 hrs/week
Responsibilities
The specialist executes radiopharmaceutical manufacturing processes, including pre-production set-up, product dissolution, and waste stream management. They are also responsible for authoring and reviewing cGMP documentation and maintaining cleanroom compliance.
Requirements
Requires an Associate's or Bachelor's degree in a STEM discipline with at least two years of experience in cGMP or related quality standards. Experience with aseptic processes and chemistry is preferred.
Full job description
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 Radiopharmaceutical Manufacturing Specialist performs duties to support manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.
Success in this role requires comfort with repetitive processes, structured schedules, and engagement in a production setting.
Responsibilities
Execute various aspects of radiopharmaceutical manufacturing, including pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
Assist in the accurate and timely preparation and completion of records manufacturing, including Batch Records, Forms, Logbooks, etc.
Review production Work Orders on the production schedule.
Author, review, and revise cGMP documentations, such as Batch Production Records (BPR), Standard Operating Procedures (SOP), Works Instructions (WI), and Production Checklists while upholding NorthStar’s QMS guidelines.
Perform safety checks and routine inspection of the production processing equipment and control systems, consumables, and cleanrooms to ensure compliant manufacturing. Notify leader of equipment or operating problems and the need for additional materials, supplies, or investigations.
Maintain accurate inventory of materials and consumables, and coordinate equipment traceability under the direction of the leader.
Perform and assist in maintaining the cleanliness and orderliness of the cleanroom and/or manufacturing spaces, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
Contribute to interdepartmental projects including production scale-up and continuous process improvement.
Early Development
After 3 months, you will:
Understand foundational cGMP and just-in-time radiopharmaceutical manufacturing principles.
Become a qualified Radiation Worker, trained in ALARA principles and isotope-specific safety protocols.
Collaborate effectively with cross-functional teams, including Quality, Science, and Engineering, to ensure timely delivery of radiopharmaceuticals for cancer treatment.
Gain hands-on experience with state-of-the-art manufacturing technology under expert supervision.
After 6 months, you will:
Achieve Qualified Operator status with demonstrated competency to execute full batch manufacturing of novel isotopes.
Contribute to Operational Excellence by maintaining optimum KPIs and metrics to enhance production efficiency and quality.
Fully integrate into NorthStar’s mission to revolutionize oncology treatment by providing patients with global access to game-changing radiopharmaceuticals.
Develop advanced technical skills in handling sophisticated manufacturing processes and technologies, positioning yourself as a key player in an innovative and impactful field.
Qualifications
Associate’s Degree (AS) in a STEM discipline and minimum two (2) years of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience; or equivalent combination of education and experience. Relevant military experience will also be considered.
Bachelor’s Degree (BS) in a STEM discipline and minimum two (2) years of cGMP (pharmaceutical or medical device), ISO 15189 (hospital), CLIA (clinical laboratory), ISO 9001 (industrial manufacturing), IATF 16949 (automotive) or AS9100 (aerospace) experience preferred. CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification 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.
Shift Information
Third shift hours are Monday - Thursday 9pm - 7:30am (shift ends Friday morning). During this position’s training period (approximately 60 days), the ability to work alternate shifts is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility. Working occasional overtime, weekends, and holidays is required.
This position is eligible for an additional $5.00/hour shift premium for any hours worked between 6:00pm and 6:00am.
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.
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.
Related keywords
RadiopharmaceuticalscGMPISO 15189CLIAISO 9001IATF 16949AS9100Aseptic ProcessingCleanroomALARABatch Production RecordsSOPWork InstructionsRadiation SafetyDosimetryBioassay Testing
One Mission. One Campus. Providing Patients Global Access to Game-Changing Radiopharmaceuticals.
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Founded
2006
Headquarters
Beloit, Wisconsin
LinkedIn followers
15,747
Total funding
$117M
NorthStar is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies.
NorthStar produces copper-67 (Cu-67) and is the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology. The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs.
For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
Offices: 1800 Gateway Boulevard, Beloit, Wisconsin 53511, US · 5249 Femrite Drive, Madison, Wisconsin 53718, US · 1601 South Providence Road, Columbia, Missouri 65211, US · 3060 Progress Rd, Madison, Wisconsin 53716, US
Health DiagnosticsHealth CareHospitalityManufacturingPharmaceuticalTherapeutics
One Mission. One Campus. Providing Patients Global Access to Game-Changing Radiopharmaceuticals.
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Founded
2006
Headquarters
Beloit, Wisconsin
LinkedIn followers
15,747
Total funding
$117M
NorthStar is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies.
NorthStar produces copper-67 (Cu-67) and is the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology. The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs.
For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
Offices: 1800 Gateway Boulevard, Beloit, Wisconsin 53511, US · 5249 Femrite Drive, Madison, Wisconsin 53718, US · 1601 South Providence Road, Columbia, Missouri 65211, US · 3060 Progress Rd, Madison, Wisconsin 53716, US
Health DiagnosticsHealth CareHospitalityManufacturingPharmaceuticalTherapeutics