Conshohocken, PA30+ days ago
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. Key Responsibilities Product & Process Technical Knowledge 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.