Senior Manager, MSAT Product Knowledge Steward

Role: Senior Manager, MSAT Product Knowledge Steward, serves as the scientific subject matter expert for small-molecule pharmaceutical products, focusing on product knowledge preservation, integration, and communication across the entire product lifecycle. Responsibilities include developing and maintaining comprehensive technical knowledge of assigned products, supporting technology transfer to CMOs through technical documentation, and managing product lifecycle activities such as process optimization and change management. The role involves collaboration with manufacturing, process engineering, quality, and regulatory teams to ensure consistent product understanding and inspection readiness. Key tasks encompass authoring and maintaining technical dossiers, supporting process validation, and contributing to technical assessments for change controls and investigations. Qualifications required are a PhD or MS in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related fields, with at least 7 years of industry experience, including 3–5 years in small-molecule process development, API manufacturing science, or technical operations supporting late-stage development and commercial manufacture. Preferred skills include experience in technology transfer, deviation investigations, and technical documentation. The position demands strong technical, analytical, and cross-functional communication skills, with an emphasis on GMP compliance and knowledge management. High-value biopharma specifics involve expertise in small-molecule APIs, lifecycle management, process validation, and cross-company technical collaboration. The role is based in a regulated environment supporting ongoing Phase 3 trials for a liver-directed therapeutic for MASH, with ongoing emphasis on process and product technical stewardship.