[Hiring] Associate Director, API / Drug Substance MSAT (Small Molecule) @Madrigal Pharmaceuticals

Role Description

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.

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.

Benefits

• Comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings.
• Equity opportunities that align individual and company performance.
• Mental health benefits through our Employee Assistance Program for employees and their family.
• Additional voluntary benefits like supplemental life insurance and legal services.