Senior MSAT, CDMO

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 improve 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.