Senior Manager, MSAT Product Knowledge Steward

Position Summary

The Senior Manager, MSAT Product Knowledge Steward is the scientific steward for assigned small-molecule pharmaceutical products, serving as the technical subject matter expert responsible for preserving, integrating, and communicating product knowledge spanning drug substance, drug product and finished goods across the entire product lifecycle—from process development through technology transfer, commercial manufacturing, and post-approval lifecycle management.

Key Responsibilities

• Develop and maintain comprehensive technical knowledge of assigned products, including formulation, process design, critical process parameters (CPPs), critical quality attributes (CQAs), and control strategies
• Coordinate technical experts across functions in capturing product knowledge
• Develops and maintains the product’s technical dossier—including process, analytical methods, controls, and key risks—serving as the single source of truth for MSAT execution
• Act as a technical knowledge owner for products within MSAT, ensuring accurate and current understanding of product and process requirements
• Support interpretation and application of product knowledge to manufacturing operations and process improvements
• Technology Transfer & Site Support
• Support technology transfer to external CMOs by authoring, reviewing, and maintaining comprehensive technical transfer and process documentation, ensuring accurate and consistent knowledge transfer from development teams or prior manufacturers
• Develop and curate CMO-facing knowledge transfer packages (e.g., process descriptions, technical summaries, manufacturing requirements) to support site readiness and technical alignment
• Provide documentation-based technical support for CMO onboarding and process introduction activities by ensuring completeness, accuracy, and traceability of technical content supporting commercial manufacturing
• Lead knowledge gap assessments for tech transfer and launch readiness, and drive closure plans in collaboration with CMC, Quality, and site/CMO partners
• Lifecycle Management Support
• Support product lifecycle activities, including post-approval changes, process optimization, continuous improvement, and deviation investigations
• Contribute technical assessments related to change control, CAPAs, and manufacturing investigations
• Aid in evaluating the technical impact of raw material changes, equipment changes, or process updates
• Cross-Functional Collaboration
• Serve as a technical liaison between MSAT and manufacturing sites for product-specific topics
• Support inspection readiness by ensuring technical product knowledge is documented and traceable
• Documentation & Knowledge Management
• Author and maintain comprehensive product knowledge packages that consolidate development history, process rationale, technical risks, control strategies, and manufacturing knowledge into a single source of truth supporting MSAT execution and technology transfer
• Ensure technical documentation aligns with GMP expectations and internal standards
• Contribute to or review technical documents such as process descriptions, technical reports, risk assessments, and knowledge summaries

Required Qualifications

• MS or PhD in Chemistry (preferred) or Bachelor’s in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline
• Minimum of 7 years of relevant pharmaceutical industry experience, including at least 3–5 years in small-molecule process development, API MSAT, manufacturing science, technical operations, or commercial manufacturing support
• Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support
• Demonstrated hands on experience supporting late-stage development, technology transfer, process validation, commercial launch, or lifecycle management of small-molecule drug substance/API processes

Preferred Qualifications

• Experience supporting technology transfer activities
• Experience contributing to deviation investigations, change controls, or process improvements
• Strong technical documentation and knowledge management skills