Senior MSAT, CDMO

NorthStar Medical Radioisotopes; Beloit (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Bonus plan

Equity Incentive Program

401(k) match

Paid holidays and PTO

Healthcare benefits

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking a Senior MSAT, CDMO to lead technology transfer, process validation, scale-up, and commercial manufacturing. This role directs cross-functional teams and represents the organization in sponsor or regulatory discussions.

The role requires mentoring of MSAT staff, guiding root cause investigations, and driving continuous improvements to manufacturing capability and product lifecycles, while maintaining strict cGMP and safety standards.

Qualifications

• Bachelor’s degree in a relevant STEM field with several years of tech transfer/validation experience in regulated manufacturing.
• Experience supporting sponsor audits and regulatory inspections in a CDMO/pharma environment.
• Lean manufacturing and continuous improvement knowledge; ability to influence across teams.

Responsibilities

• Lead technology transfer, validation, scale-up, and commercial manufacturing activities.
• Provide technical oversight and troubleshoot manufacturing operations for safe, compliant execution.
• Develop and maintain technical documentation: protocols, reports, batch records.
• Lead investigations for deviations and CAPAs with risk assessment and root cause analysis.
• Represent the organization in sponsor/regulatory interactions and audits.
• Mentor MSAT teammates and drive continuous improvement initiatives.
• Collaborate across Manufacturing, Quality, Product Development, and Validation to support programs.
• Ensure compliance with safety and regulatory standards (cGMP/FDA, OSHA, etc.).

Skills

Technology transfer

Process validation

Scale-up

Regulatory interactions

Cross-functional leadership

Education

Bachelor’s degree in a relevant STEM field

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 Senior MSAT, CDMO role serves as a technical leader and subject matter expert responsible for complex technology transfer, process validation, scale-up, and commercial manufacturing. This role provides strategic technical direction, leads high-impact investigations and improvement efforts, and represents the organization during sponsor or regulatory interactions, audits, etc. The position influences organizational capability through technical mentorship, cross-functional leadership, and the advancement of manufacturing excellence across multiple programs.

Responsibilities

• Serve as a technical lead for technology transfer, commercialization, manufacturing scale-up, and product lifecycle activities from development through commercial manufacturing
• Provide strong technical oversight to manufacturing operations and lead troubleshooting activities to ensure safe, compliant, and effective process execution.
• Establish and maintain standards for technical documentation including protocols, reports, batch records, and process descriptions.
• Conduct advanced technical evaluations of process performance, identify systemic improvement opportunities, and recommend long-term optimization strategies 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.
• Build alignment amongst cross-functional activities among Manufacturing, Quality, Product Development, Validation, and other functional groups to support manufacturing needs.
• Provide guidance and technical leadership for process characterization studies, validation activities, continued process verification efforts, and commercial readiness activities.
• Act as the primary SME during sponsor or regulatory interactions, audits, or inspections.
• Manage complex technical projects, managing risks, priorities, schedules, and technical deliverables to achieve business objectives.
• Mentor and develop other MSAT team members by providing technical coaching, knowledge transfer, and development guidance while influencing organizational capability without direct authority.
• 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:

• Expand expertise in process characterization, validation strategy, and advanced risk assessments
• Serve as the primary representative during sponsor or regulatory interactions, audits, or inspections
• Mentor MSAT team members and influence best practices within the CDMO organization

After 6 months, you will:

• Develop recognized subject matter expertise in manufacturing principles
• Influence strategic approaches and product lifecycles across multiple programs
• Establish and implement long-term continuous improvement roadmaps that support operational excellence and commercial growth

Qualifications

MINIMUM EDUCATION/EXPERIENCE

• Bachelor’s degree in a relevant STEM field with a minimum of six (6) 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.
• 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.
• Demonstrated ability to influence without direct authority, manage competing priorities, and build collaborative relationships across the organization.
• Knowledge of Lean manufacturing, continuous improvement methodologies, and operational excellence principles.

PREFERRED EDUCATION/EXPERIENCE

• Experience with radiopharmaceutical process development, upstream processing, downstream processing, or fill-finish operations.
• Demonstrated experience managing cross-functional technical projects and delivering complex programs in a fast-paced manufacturing environment.

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.