Manager, Product Technical Knowledge Specialist (MSAT)
Position Summary
The Manager, Product Technical Knowledge Specialist (MSAT) serves as a technical subject matter expert for assigned small molecule pharmaceutical products, supporting the full product lifecycle from technology transfer through commercial manufacturing and post-approval changes.
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.
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.
Supports interpretation and application of product knowledge to manufacturing operations and process improvements.
Supports 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.
Supports product lifecycle activities, including post-approval changes, process optimization, continuous improvement, and deviation investigations.
Collaborates with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC to ensure consistent product understanding.
Supports inspection readiness by ensuring technical product knowledge is documented and traceable.
Required Qualifications
Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline.
Minimum of 8 years experience, 3–5 years of experience in MSAT, process engineering, manufacturing support, or pharmaceutical technical operations.
Familiarity with GMP manufacturing environments.
Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support.
Preferred Qualifications
Experience supporting technology transfer activities.
Familiarity with biologics or small-molecule manufacturing (as applicable).
Experience contributing to deviation investigations, change controls, or process improvements.
Strong technical documentation and knowledge management skills.