Associate Director, MSAT API

ppMadrigal 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. /p pOur 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. /p h3Position Summary /h3 pProvides site-facing MSAT leadership and day-to-day technical oversight for an assigned 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. /p h3Key Responsibilities /h3 h3CMO Technical Oversight /h3 ul liAct as primary MSAT technical interface for assigned CMO, run technical governance routines and performance monitoring /li liCoordinate technical issue resolution and improvement actions with owners, timelines, and effectiveness checks /li liProduce deliverables such as weekly/monthly governance packs, issue logs, and improvement action trackers /li /ul h3Transfers, Changes Readiness /h3 ul liLead readiness tracking for transfers/changes (data, protocols, milestones), elevate risks, and align mitigations /li liAssess impacts to process understanding/control strategy and coordinate alignment with CMC/Quality /li liProduce deliverables such as readiness trackers, change impact assessments, and technical risk briefs /li /ul h3Quality Event Support Documentation /h3 ul liProvide technical input to deviations/investigations/CAPAs with Quality, ensure high-quality, timely closure /li liMaintain inspection-ready documentation and knowledge management for assigned CMO scope /li liProduce deliverables such as technical narratives, evidence packages, and knowledge repositories /li /ul h3Required Qualifications /h3 ul liBS+ Engineering / Life Science (or related) /li li10–12 years MSAT / process engineering / CMC API support with external site readiness delivery /li liDemonstrated partner-facing technical leadership and issue management /li /ul h3Preferred Qualifications /h3 ul liExperience in pharmaceutical / biotech supporting CMO audits / inspections and regulatory responses (preferred) /li liMulti-site / partner oversight experience /li /ul h3Key Competencies /h3 ul liCMO-facing technical oversight, governance routines, and performance monitoring, issue triage, and closure discipline /li liTech transfer execution, readiness tracking, and milestone governance, dependency, and risk management /li liDeviation/investigation/CAPA technical support, root cause rigor and prevention focus in partner settings /li liChange impact assessment and control strategy awareness, inspection-ready documentation, and knowledge management /li liCross-functional leadership, escalation, and executive-ready technical risk/decision communication /li /ul pWe 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. /p pPlease 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. /p pUnsolicited 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. /p /p #J-18808-Ljbffr