Associate Director, MSAT 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

Provides site-facing MSAT leadership and day-to-day technical oversight for an assigned small molecule API CMO. Serves 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.

Key Responsibilities

CMO Technical Oversight

• Act as primary small molecule API 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), escalate risks, and align mitigations
• Assess impacts to process understanding / 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, ensure 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

Required Qualifications

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

Preferred Qualifications

• Experience in pharmaceutical / biotech supporting CMO audits / inspections and regulatory responses (preferred)
• Multi-site / external partner oversight experience

Key Competencies

• CMO-facing technical oversight, governance routines, and performance monitoring, issue triage, and closure discipline
• Tech transfer execution, readiness tracking, and 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

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.