Senior Manager, MSAT Product Steward

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH.

Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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. The ideal candidate is an experienced Process Development scientist who enjoys organizing complex technical knowledge as much as generating it.

This role combines deep scientific expertise with product knowledge stewardship, ensuring critical manufacturing, process, and control strategy knowledge is captured, maintained, and translated into high-quality technical documentation and guidance that enables successful technology transfer and commercial manufacturing.

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
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
Leads knowledge gap assessments for tech transfer and launch readiness, and drives closure plans in collaboration with CMC, Quality, and site/CMO partners