Senior Radiopharmaceutical Manufacturing Specialist (3rd Shift)

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Healthcare FSA and Dependent Care FSA

Company-paid disability (short-term &长

Company-paid life insurance & AD&D

401(k) match

Paid holidays and PTO

Paid parental leave

Equity Incentive Program

Lump sum relocation benefit

Job summary

NorthStar Medical Radioisotopes in Beloit, WI is seeking a Senior Radiopharmaceutical Manufacturing Specialist to support production of radiopharmaceuticals, oversee equipment preparation, batch dissolution, and dispensing of medical radioisotopes in a cGMP environment.

The role emphasizes mentorship, accurate record-keeping (BPR, SOP, WI), and collaboration with quality, science, and engineering teams to ensure compliant, on-time delivery of radiopharmaceuticals.

Qualifications

• Associate’s Degree in a STEM discipline and minimum four years of cGMP pharmaceutical experience; or BS in STEM with four years of cGMP experience.
• CDMO/CMO experience, chemistry experience and knowledge of aseptic processes and equipment qualification preferred.
• Company cannot provide immigration sponsorship; Form I-9 required on first day of employment.

Responsibilities

• Operate as SME across radiopharmaceutical manufacturing including intermediate and finished dose production processes.
• Mentor and train new manufacturing personnel on safety, quality, and production systems.
• Prepare and complete Batch Records, Forms, Log Books, etc.
• Participate in internal and external audits and assist with auditor interactions.
• Support business development through interaction with sponsors.
• Plan and organize production Work Orders on the schedule with leadership.
• Author, review, and revise cGMP documentation (BPR, SOP, WI, Production Checklists).
• Perform safety checks and inspections of equipment, consumables, and cleanrooms; notify leadership of issues.
• Maintain inventory and coordinate equipment traceability under leadership.
• Engage in all workflows inside QMS including deviations, OOSs, change controls, DCO, and CAPA.
• Contribute to projects in production scale-up, development, and continuous improvement.

Skills

cGMP experience

Radiopharmaceutical manufacturing

Documentation (BPR/SOP/WI)

Audits & QA

Cross-functional collaboration

Education

Associate’s Degree in STEM

Bachelor’s Degree in STEM

Tools

QMS software

Batch Records management

Job description

Position

The Senior Radiopharmaceutical Manufacturing Specialist performs duties to support manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, batch dissolution, product synthesis, dispensing of medical radioisotopes, and aliquoting of finished patient doses, 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

• Operate as Subject Matter Expert (SME) across various aspects of radiopharmaceutical manufacturing including but not limited to the manufacturing of the intermediate and finished dose production processes. This includes pre-production set-up, manufacturing processes, post-production activities, and waste stream management.
• Mentor and train new manufacturing personnel on all safety, quality, and production systems.
• Assist in the accurate and timely preparation and completion of records related to manufacturing, including Batch Records, Forms, Log Books, etc.
• Participate in internal and external compliance audits and assist with auditor interactions as needed.
• Support the business development team in interaction with current and potential sponsors.
• Plan and organize production Work Orders on the production schedule in collaboration with leadership.
• 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 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 facility, equipment, and materials in accordance with NorthStar’s respective policies and procedures.
• Engage in completion of all workflows inside QMS including deviations, OOSs, change controls, document changes (DCO), and CAPA. Work cross-functionally on employing standardized root cause analysis, investigation tools and methodologies.
• Contribute to interdepartmental projects including production scale-up, product development, continuous process improvement which includes qualification and validation activities.
• Work with Facilities and Maintenance group on preventative maintenance (PM) review and troubleshooting implementation plan, and assist in tracking scheduled system maintenance and equipment calibrations while keeping an open line of communication.
• Monitor product quality to ensure compliance with standards and specifications by identifying and verifying appropriate materials, area conditions, and process for production. Communicate any abnormalities to the leader.

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 four (4) years of cGMP (pharmaceutical) 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 four (4) years of cGMP (pharmaceutical) experience preferred. CDMO/CMO experience, chemistry experience and knowledge of aseptic processes (cleanroom environment) and equipment qualification preferred.

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.

• 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
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• 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)

• 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 located in Beloit, Wisconsin. The headquarters and primary manufacturing facility are in Beloit.

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.