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

Associate Director, API / Drug Substance MSAT (Small Molecule) page is loaded## Associate Director, API / Drug Substance MSAT (Small Molecule)locations: PA - Conshohocken - Officetime type: Full timeposted on: Posted Yesterdayjob requisition id: JR\_000696Madrigal 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, 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**Preferred Qualifications*** Experience supporting regulatory inspections at CMOs* Proven track record managing post-approval changes in commercial portfolios* Experience overseeing multiple CMOs or global manufacturing networks**Key Competencies*** Technical authority and risk-based decision-making* Ability to lead without direct control in a virtual organization* Strong scientific judgment and attention to detail* Clear, concise technical communication suitable for regulators and senior leadership* Executive-level presence appropriate for Associate Director**Location & Travel Requirements:*** US Remote* Up to 50% travel to manufacturing sites across the supply network.Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $169,000 - $206,600 per year. We comply with all applicable minimum wage laws.All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact View email address on click.appcast.io. Madrigal is an Equal Opportunity Employer. All employment is decided on the #J-18808-Ljbffr