Director, MSAT API 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.

Position Summary Owns end-to-end technical oversight of API supply performance and continuity across external manufacturing. Establishes API technical governance with CMOs focused on process robustness, performance monitoring, and elimination of recurring supply-impacting issues. Coordinates with CMC and Quality to execute tech transfers, ensuring readiness criteria, milestones, and risks are actively managed. Leads technical triage and input to deviations, investigations, and CAPAs with clear root cause and prevention actions. Assesses technical / compliance impacts of process / material / site changes and maintains inspection-ready technical documentation and product / process knowledge.

Key Responsibilities

Technical Governance & Performance Monitoring

• Own CMO technical governance model and performance monitoring, define escalation triggers and recurring issue elimination plans
• Drive process robustness improvements (yield, cycle time, reliability) aligned to supply requirements
• Produce deliverables such as CMO technical governance packs, technical performance scorecards, and recurring-issue elimination plans

Tech Transfers & Readiness

• Coordinate transfer readiness with CMC / Quality (data packages, milestones, readiness criteria) and ensure execution tracking
• Escalate technical risks early and align mitigation plans to supply milestones
• Produce deliverables such as tech transfer readiness trackers, milestone dashboards, and risk / decision briefs

Investigations, CAPA & Change Impact

• Lead technical input to deviations / investigations / CAPAs, ensure timely, compliant closure and prevention actions
• Assess change impacts (process / material / site) and align implications to control strategy and supply risk
• Produce deliverables such as technical assessments, change impact memos, and CAPA effectiveness summaries

Required Qualifications

• BS+ Engineering / Science (or related)
• 12–15 years MSAT / process engineering / CMC support for API (CMOs)
• Demonstrated technical issue resolution leadership and documentation rigor

Preferred Qualifications

• Experience in pharmaceutical / biotech GMP manufacturing and supporting CMO audits / inspections (preferred)
• Experience leading multi-product / multi-CMO technical governance and tech transfer execution

Key Competencies

• API technical governance, process monitoring, and robustness improvement (yield, cycle time, reliability), technical risk identification
• Tech transfer readiness planning, milestone governance, and cross-functional dependency management (CMC, Quality, sites / CMOs)
• Deviation / investigation / CAPA technical leadership, root cause rigor, prevention actions, and compliant closure
• Change impact assessment (process / material / site) and control strategy awareness, inspection-ready documentation discipline
• Partner governance and performance management across CMOs, escalation and executive-ready technical risk communication

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.

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