Manager, Product Technical Knowledge Specialist (MSAT)
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 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. This role is responsible for maintaining deep technical understanding of product formulation, process, and manufacturing controls, and for ensuring continuity of product knowledge across development, manufacturing sites, and lifecycle activities. The position operates within MSAT and partners cross-functionally with Quality, Supply Chain, Regulatory CMC, and External Manufacturing to own and manage MSAT technical documentation and knowledge transfer materials supporting manufacturing performed exclusively at external CMOs.
Requirements
- 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
- Working knowledge of GMP manufacturing environments
- Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support
Nice To Haves
- 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
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.
- 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
- Contribute to or review technical documents such as process descriptions, technical reports, risk assessments, and knowledge summaries
- Support maintenance of product knowledge repositories and MSAT documentation systems
- Ensure technical documentation aligns with GMP expectations and internal standards
Benefits
- flexible paid time off
- medical, dental, vision and life/disability insurance
- 401(k) offerings (i.e., traditional, Roth, and employer match)
- supplemental life insurance
- legal services
- mental health benefits through our Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
