Senior MSAT, CDMO

Overview

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.