Senior Manager, External Manufacturing - API

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.

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.

Position Summary

The Senior Manager, API External Manufacturing Lead is responsible for supporting API manufacturing execution, performance monitoring, and supply continuity across Madrigal's external API manufacturing network.

This role serves as the primary operational liaison for assigned API CMOs, ensuring approved supply plans are translated into executable manufacturing activities and that production, release, and delivery milestones are achieved.

The role leads the day-to-day activities of the API Virtual Plant Team, coordinating cross-functional Madrigal SMEs across MSAT, CMC, Quality, Regulatory, Procurement, Planning, and Finance to monitor performance, resolve operational constraints, and support readiness for key manufacturing and lifecycle milestones.

This position manages API CMO governance activities, performance tracking, issue escalation, recovery planning, and execution-related risk management.

In partnership with Procurement, MSAT, CMC, Quality, and Planning, this role supports the ongoing development and optimization of the API manufacturing network, including onboarding and qualification activities for new API vendors to improve supply reliability, flexibility, and long-term network resilience.

Key Responsibilities

• Manufacturing Performance & Supply Continuity
• Monitor API manufacturing performance across assigned CMOs through established KPIs, governance processes, and routine performance reviews.
• Ensure execution alignment to approved demand and supply plans by tracking capacity, inventory levels, and key planning assumptions.
• Support API continuity planning activities by identifying risks and coordinating mitigation actions with internal and external stakeholders.
• Maintain visibility of manufacturing performance through scorecards, capacity reviews, and continuity planning updates.
• Issue Management & Recovery Execution
• Coordinate resolution of API supply constraints, including capacity limitations, material shortages, and quality-related events, working closely with CMOs and internal stakeholders.
• Develop and track recovery plans, ensuring timely execution of corrective actions and escalation of critical issues.
• Communicate recovery options, timelines, and associated trade-offs to management and cross-functional teams.
• Maintain issue logs, recovery plans, and escalation documentation to support effective decision-making.
• External Manufacturing Oversight – Virtual Plant Team
• Lead cross-functional coordination activities supporting API manufacturing execution and milestone readiness.
• Partner with MSAT, CMC, and Quality to support tech transfers, deviations, investigations, and change management activities.
• Facilitate routine governance meetings and performance reviews with CMOs and internal stakeholders.
• Develop and maintain readiness trackers, action registers, and cross-functional dependency plans to support reliable execution.
• Quality & Compliance Support
• Partner with Quality and MSAT to support deviation management, disposition activities, and compliance-related initiatives impacting supply execution.
• Support inspection readiness efforts through maintenance of appropriate documentation and execution records.
• Contribute to development of readiness packages, governance materials, and audit-support documentation as needed.
• Required Qualifications
• BS or higher degree in Supply Chain, Engineering, Science, or related field.
• 7-10 years of experience in pharmaceutical or biotechnology manufacturing, external supply management, or API operations within an outsourced manufacturing environment.
• Experience supporting API manufacturing performance management, including CMO oversight, issue resolution, and execution of recovery plans.
• Demonstrated ability to work effectively across MSAT, CMC, Quality, Planning, Procurement, and external manufacturing partners.
• Preferred Qualifications
• Experience in pharmaceutical or biotechnology API manufacturing within a multi-CMO outsourced network.
• Experience supporting commercial supply, product launches, or lifecycle management initiatives.
• Familiarity with long lead-time materials, campaign manufacturing, capacity planning, and supply constraint management.
• Key Competencies
• API Manufacturing Execution & Performance Management
• Ability to monitor API manufacturing performance, support governance processes, and drive execution against supply commitments.
• Issue Resolution & Recovery Coordination
• Ability to identify operational risks, coordinate recovery activities, and facilitate timely resolution of manufacturing constraints.
• Cross-Functional Collaboration
• Strong ability to collaborate across MSAT, CMC, Quality, Planning, Procurement, and external partners to achieve business objectives.
• Quality & Technical Partnership
• Effective partnership with Quality and MSAT teams to support deviations, change controls, tech transfers, and manufacturing readiness activities.
• Operational Excellence & Execution Discipline
• Strong organizational skills, attention to detail, and ability to maintain governance processes, documentation, and execution tracking mechanisms.

We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics.

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Please note that this job description is not exhaustive and may evolve over time.

Only shortlisted candidates will be contacted.

Applicants must be authorized to work in the country of employment at the time of application.

Employment terms, where applicable, will be governed by relevant collective bargaining agreements.

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