Associate Director, API / Drug Substance MSAT (Small Molecule)

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 Associate Director, API / Drug Substance MSAT (Small Molecule) is the internal technical authority for commercial small-molecule drug substance manufacturing executed entirely through external CMOs. This role provides end-to-end technical oversight, governance, and lifecycle stewardship to ensure robust, compliant, and reliable commercial API supply.

Operating in a virtual manufacturing environment, the role focuses on technical decision-making, CMO oversight, post-approval change management, and inspection readiness, rather than hands-on process execution. The Associate Director partners closely with Quality, Supply Chain, External Manufacturing, and Regulatory CMC to manage technical risk and maintain continuity of product and process knowledge across the external manufacturing network.

Key Responsibilities

Technical Authority & Governance

• Serve as the internal MSAT technical owner for assigned commercial small-molecule drug substance processes
• Establish and maintain deep understanding of API synthetic routes, unit operations, impurity profiles, and control strategies
• Provide final MSAT technical assessment and recommendations for manufacturing decisions impacting product quality or supply

CMO Technical Oversight

• Act as the primary technical interface with CMOs for drug substance topics - occasional support outside standard business hours may be required to address critical manufacturing or quality events.

• Review, challenge, and approve CMO-proposed technical changes, investigations, and optimization activities
• Ensure CMOs operate within the approved process and control strategy, with appropriate technical justification for deviations

Commercial Lifecycle Management

• Lead MSAT technical evaluation of post-approval changes, including site changes, raw material changes, equipment updates, and process modifications
• Ensure changes are scientifically sound, compliant, and aligned with regulatory commitments
• Drive lifecycle robustness and supply reliability through risk-based technical oversight

Deviation, OOS & CAPA Support

• Provide technical leadership for significant deviations, OOS events, and recurring trends at CMOs
• Assess root cause analyses and corrective actions for technical adequacy and long-term effectiveness
• Ensure learnings are incorporated into process understanding and governance expectations

Inspection Readiness & Regulatory Support

• Support regulatory inspections of CMOs by providing drug substance technical narratives and subject matter expertise
• Contribute technical content for regulatory submissions, responses, and variations related to commercial API manufacturing
• Ensure technical documentation and product knowledge are inspection-ready at all times

Cross-Functional Leadership

• Partner with Quality, External Manufacturing, Supply Chain, and Regulatory CMC to align on technical risk, supply strategy, and lifecycle priorities
• Represent MSAT in cross-functional governance forums and escalation discussions
• Influence external partners and internal stakeholders through technical expertise and sound judgment

Knowledge Management

• Ensure drug substance process knowledge is captured, current, and maintained across the external manufacturing network
• Oversee technical knowledge transfer when onboarding new CMOs or transferring manufacturing sites

Required Qualifications

• PhD in Chemistry,