Director, API External Manufacturing Lead

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.

Key Responsibilities

• Owns API supply oversight, execution performance, and continuity planning across external manufacturing partners.
• Aligns demand, capacity, lead times, and inventory strategy into an execution plan and maintains governance routines with sites / CMOs to monitor performance and risk.
• Leads escalation and resolution of supply-impacting constraints and exceptions and coordinates cross-functional recovery plans.
• Partners with CMC / MSAT and Quality to manage supply impact of deviations, investigations, changes, and tech transfers.
• Ensures key planning assumptions, parameters, and documentation remain current to support predictable execution.
• Performance Governance & Continuity Planning
• Own API performance KPIs, governance cadence, and continuity plans across sites / CMOs.
• Align capacity and inventory strategy to demand commitments, maintain key planning assumptions / parameters.
• Produce deliverables such as CMO / site performance scorecards, continuity plans, and quarterly capacity reviews.
• Exception Management & Recovery
• Lead escalation and resolution for constraints (capacity, materials, quality events), coordinate recovery actions and communications.
• Provide clear options, trade-offs, and timelines, ensure action ownership and closure.
• Produce deliverables such as recovery plans, escalation briefs, and decision logs.
• Technical / Quality Interfaces
• Partner with CMC / MSAT / Quality on tech transfers, deviations, and changes, ensure readiness for major milestones.
• Maintain aligned documentation and governance artifacts supporting reliable execution.
• Produce deliverables such as readiness trackers and cross-functional dependency maps.
• Required Qualifications
• BS+ (Supply Chain, Engineering, Science, or related)
• 12–15 years in API supply / manufacturing planning and performance management, including issue triage
• Demonstrated cross-functional coordination and escalation leadership
• Preferred Qualifications
• Experience in pharmaceutical / biotech API manufacturing and multi-CMO governance (preferred)
• Experience supporting launches, network changes, and long lead-time constraint management
• Key Competencies
• API supply oversight, continuity planning, and partner governance, KPI cadence and performance recovery management
• Constraint management, scenario options, and recovery execution, decision trade-offs, and timely escalation
• Cross-functional leadership, escalation, and executive-ready risk / decision communication
• Interface management with Quality and CMC / MSAT (deviations, changes, transfers), milestone readiness discipline
• Planning assumptions / parameter governance, documentation rigor, and plan-to-execution reliability

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

Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws.

Further information about how your personal data is processed, together with details of your rights and how to exercise them, is available in our Job Applicant Privacy Notice, which is made available to you if you apply through Workday.

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.

Unsolicited resumes from agencies should not be forwarded to Madrigal.

Madrigal will not be responsible for any fees arising from the use of resumes through this source.

Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Join our growing team focused on transforming the treatment of people with liver diseases.

Madrigal is an Equal Opportunity Employer.

All employment is decided on the basis of qualifications, merit, and business need.

Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

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