MSAT II, CDMO

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 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
• 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.)

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.