Associate Director, Manufacturing Technical Project Management (MSAT)

About this role

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 Manufacturing Technical Project Manager (MSAT) is responsible for leading and coordinating technical projects supporting commercial pharmaceutical manufacturing executed primarily through external contract manufacturing organizations (CMOs). The role serves as the MSAT project lead for drug substance (API)–focused initiatives, while also supporting end-to-end CMC projects spanning drug substance, drug product, and supply readiness as required. Operating within MSAT, the role ensures cross-functional alignment, disciplined execution, and timely delivery of technical objectives related to technology transfer, lifecycle changes, and manufacturing readiness. The position works closely with MSAT technical SMEs, Quality, Supply Chain, Regulatory CMC, and external partners, and does not own commercial, regulatory strategy, or medical activities. The role will lead a team of internal and/or contingent resources and will progressively assume responsibility for building, managing, and developing a team of MSAT project management professionals as the organization scales. Key Responsibilities Technical Project Leadership • Lead MSAT technical projects supporting commercial manufacturing, with primary focus on drug substance (API) activities at external CMOs • Develop and manage integrated project plans, timelines, and deliverables for technical initiatives • Drive execution of MSAT-owned activities while coordinating inputs from cross-functional stakeholders

Team Leadership & Resource Management • Lead and develop a blended team of MSAT project managers covering both internal and contingent resources as the organization scales • Own delivery coordination of all MSAT-led programs, including work allocation, deliverable quality, performance expectations, and integration with internal teams • Establish clear roles, responsibilities, objectives, and development priorities for team members and allocate resources across the MSAT project portfolio based on technical complexity, business priority, capacity, and project timing • Provide coaching and feedback to team members and help develop the organization’s future MSAT project-management capabilities

CMO-Focused Project Management • Serve as the primary MSAT project interface with CMOs for assigned initiatives • Coordinate technical deliverables, timelines, and dependencies with external manufacturing partners • Facilitate regular project reviews, risk discussions, and issue resolution with CMOs

Drug Substance / API Project Scope • Manage projects related to API technology transfer, process changes, site onboarding, and manufacturing readiness • Coordinate MSAT technical inputs for investigations, process improvements, and lifecycle initiatives affecting drug substance manufacturing • Ensure alignment between CMO execution and approved process understanding and control strategy

End-to-End CMC Project Support • Lead or support integrated CMC projects spanning drug substance (DS), drug product (DP), and supply chain readiness as needed • Coordinate handoffs and dependencies across DS, DP, Quality, Regulatory CMC, and Supply Chain teams • Maintain visibility into cross-functional risks and mitigation plans impacting overall project timelines

Risk, Issue & Change Management • Identify, track, and escalate technical and execution risks related to manufacturing projects • Support management of project-related changes, including scope, timelines, and technical dependencies • Ensure issues are documented, communicated, and resolved through appropriate governance channels

Communication & Governance • Prepare and deliver clear project updates to MSAT leadership and cross-functional teams • Support project governance forums, decision tracking, and documentation • Ensure project execution aligns with GMP requirements and internal MSAT standards

Required Qualifications • Bachelor’s degree in Engineering, Chemistry, Pharmaceutical Sciences, or a related technical discipline • 10-12 years of experience in pharmaceutical manufacturing, MSAT, technical operations, or technical project management • Demonstrated experience managing projects involving external CMOs • Strong understanding of pharmaceutical manufacturing processes, preferably drug substance (API)

Preferred Qualifications • Experience supporting small-molecule drug substance manufacturing • Experience managing end-to-end CMC or technical operations projects • Familiarity with GMP environments and regulated project execution • Experience building or managing technical, project-management, or matrixed teams in a pharmaceutical or other regulated environment • PMP or equivalent project management certification (a plus, not required)

Key Competencies • Strong technical project management skills • Ability to lead cross-functional teams without direct authority • Effective communication with intern

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