Associate Director, MSAT API

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH).

Provides site‑facing MSAT leadership and day‑to‑day technical oversight for an assigned API CMO. Acts as the primary technical interface to monitor performance, coordinate investigations, and close technical issues that could impact supply. Leads readiness tracking for tech transfers and lifecycle changes, aligning data packages, milestones, and risk controls with CMC and Quality. Assesses technical risk for process/material/site changes and escalates impacts early with clear options.

Partners with the CMO to drive sustained improvements and maintain inspection‑ready technical documentation and knowledge management.

• CMO Technical Oversight
  • Act as primary MSAT technical interface for assigned CMO, run technical governance routines and performance monitoring.
  • Coordinate technical issue resolution and improvement actions with owners, timelines, and effectiveness checks.
  • Produce deliverables such as weekly/monthly governance packs, issue logs, and improvement action trackers.
• Transfers, Changes & Readiness
  • Lead readiness tracking for transfers/changes (data, protocols, milestones), escalating risks and aligning mitigations.
  • Assess impacts to process understanding and control strategy and coordinate alignment with CMC/Quality.
  • Produce deliverables such as readiness trackers, change impact assessments, and technical risk briefs.
• Quality Event Support & Documentation
  • Provide technical input to deviations/investigations/CAPAs with Quality, ensuring high‑quality, timely closure.
  • Maintain inspection‑ready documentation and knowledge management for assigned CMO scope.
  • Produce deliverables such as technical narratives, evidence packages, and knowledge repositories.

• BS+ in Engineering / Life Science (or related).
• 10–12 years MSAT / process engineering / CMC API support with external site readiness delivery.
• Demonstrated partner‑facing technical leadership and issue management.

• Experience in pharmaceutical/biotech supporting CMO audits/inspections and regulatory responses.
• Multi‑site/partner oversight experience.

• CMO‑facing technical oversight, governance routines, and performance monitoring; issue triage and closure discipline.
• Tech transfer execution, readiness tracking, milestone governance, dependency, and risk management.
• Deviation/investigation/CAPA technical support, root‑cause rigor and prevention focus in partner settings.
• Change impact assessment and control strategy awareness, inspection‑ready documentation, and knowledge management.
• Cross‑functional leadership, escalation, and executive‑ready technical risk/decision communication.

Applicants must be authorized to work in the country of employment at the time of application. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need.

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