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

Madrigal Pharmaceuticals•Conshohocken, PA

17h•Remote

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. 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.

Requirements

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline or MS with extensive relevant industry experience
10+ years of experience in small-molecule drug substance MSAT, technical operations, or process chemistry within commercial manufacturing
Demonstrated experience operating in virtual or CMO-centric manufacturing models
Strong understanding of GMP and regulatory expectations for commercial API manufacturing

Nice To Haves

Experience supporting regulatory inspections at CMOs
Proven track record managing post-approval changes in commercial portfolios
Experience overseeing multiple CMOs or global manufacturing networks

Responsibilities

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
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
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
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
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
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
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