Senior Manager, MSAT Product Knowledge Steward

Madrigal Pharmaceuticals•Conshohocken, PA

13d•$156,000 - $184,000

About The Position

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. 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. 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.

Requirements

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.
Working knowledge of GMP manufacturing environments
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
Strong technical and analytical skills
Ability to synthesize complex technical information and apply it to manufacturing scenarios
Effective cross-functional communication in a regulated environment
Attention to detail and commitment to compliance
Ability to work independently while contributing as part of a matrixed team
Deep scientific curiosity combined with a passion for organizing, documenting and preserving complex API process knowledge while serving as the long-term technical steward for commercial products.

Nice To Haves

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

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
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
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
Assist in evaluating the technical impact of raw material changes, equipment changes, or process updates
Collaborate with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC to ensure consistent product understanding
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
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