MSAT II, CDMO

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Paid Holidays PTO

Bonus Plan

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking an MSAT II to independently lead technology transfer, process validation, scale-up, and commercial manufacturing activities within a CDMO environment.

You will be the primary technical resource for manufacturing operations, investigations, and cross‑functional project execution. Work involves process improvements, sponsor coordination, and ensuring regulatory compliance in a fast‑growing radiopharmaceutical setting.

Qualifications

• Bachelor’s degree in a relevant STEM field with at least six years of regulated experience in tech transfer, validation or commercial manufacturing.
• Knowledge of Lean manufacturing and operational excellence principles.
• Preferred: experience in CDMO, biopharma, or pharma; regulatory audits/inspections.
• Lean Six Sigma Green Belt or higher preferred.

Responsibilities

• Lead technology transfer, scale‑up, and lifecycle activities from development to commercial manufacturing.
• Provide technical support to manufacturing operations and lead troubleshooting for compliant processes.
• Generate and review protocols, reports, batch records, and process descriptions.
• Collect and analyze manufacturing data, identify trends, and drive improvements.
• Lead investigations for deviations and non‑conformances with root cause analysis.
• Coordinate cross‑functional activities across Manufacturing, Quality, Development, and Validation.

Skills

Lean Manufacturing

Technology Transfer

Process Validation

Root Cause Analysis

Data Analysis

Cross-functional Collaboration

Education

Bachelor’s degree in STEM

Six years experience in regulated manufacturing

Tools

CAPA System

cGMP/Regulatory Environment

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 MSAT II, CDMO role independently leads technical activities supporting technology transfer, process validation, scale-up, and commercial manufacturing activities within a CDMO environment. This role serves as a primary technical resource for manufacturing operations, investigations, process monitoring, and cross-functional project execution. The position drives process improvements, manages technical deliverables, and regularly interfaces with sponsors and internal stakeholders to ensure successful program outcomes.

Responsibilities

• Lead technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide technical support to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Generate, update, and review technical documentation including protocols, reports, batch records, and process descriptions.
• Collect and analyze manufacturing performance data, identify trends, and develop data driven recommendations to improvements process robustness and operational efficiency.
• Lead investigations including deviations, non-conformances, manufacturing events, and out-of-specification results by gathering data and performing risk assessments or root cause analysis.
• Contribute to and review change controls, CAPAs, and quality system records to ensure technical accuracy and compliance.
• Coordinate cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Lead process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Manage technical workstreams, establish priorities, and ensure project deliverables meet business and sponsor needs per established project timelines.
• Lead continuous improvement initiatives utilizing Lean, root cause analysis, and operational excellence methodologies.
• Develop training programs and provide training to Operations on manufacturing processes and equipment.
• Provide on-the-floor and standby (on-call) technical support to manufacturing as required.
• Perform all duties and responsibilities in compliance with safety and regulatory standards (e.g., cGMP/FDA, OSHA, DOT, WI DHS, etc.).

Early Development

After 3 months, you will:

• Lead a technology transfer, process validation, or manufacturing support project with cross-functional coordination
• Conduct technical assessments and provide recommendations for process improvements
• Strengthen sponsor communication and presentation skills through sponsor interactions

After 6 months, you will:

• Lead technology transfer, process validation, or manufacturing support activities with minimal oversight
• Become lead for a specific sponsor, process, product or manufacturing function
• Implement a process improvement with measurable effect on process capability, compliance, efficiency, or throughput

Qualifications

MINIMUM EDUCATION/EXPERIENCE

• Bachelor’s degree in a relevant STEM field with a minimum of six (3) years relevant technical experience (technology transfer, product development, process validation, or commercial manufacturing) in a regulated industry and/or medical/pharmaceutical manufacturing environment; or an equivalent combination of education and experience.
• Knowledge of Lean manufacturing, continuous improvement methodologies, and operational excellence principles.

PREFERRED EDUCATION/EXPERIENCE

• Experience supporting manufacturing programs within a CDMO, biopharmaceutical, biotechnology, or pharmaceutical environment.
• Working knowledge of regulatory requirements and industry guidance, with experience supporting sponsor audits and regulatory inspections.
• Experience with radiopharmaceutical process development, upstream processing, downstream processing, or fill-finish operations.

PREFERRED CERTIFICATIONS

• Lean Six Sigma Green Belt or higher certification

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.