StellenbeschreibungppMadrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction‑associated steatohepatitis (MASH). /ph3Position Summary /h3pProvides 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. /ph3Key Responsibilities /h3ullibCMO Technical Oversight /bulliAct as primary MSAT technical interface for assigned CMO, run technical governance routines and performance monitoring. /liliCoordinate technical issue resolution and improvement actions with owners, timelines, and effectiveness checks. /liliProduce deliverables such as weekly/monthly governance packs, issue logs, and improvement action trackers. /li /ul /lilibTransfers, Changes Readiness /bulliLead readiness tracking for transfers/changes (data, protocols, milestones), escalating risks and aligning mitigations. /liliAssess impacts to process understanding and control strategy and coordinate alignment with CMC/Quality. /liliProduce deliverables such as readiness trackers, change impact assessments, and technical risk briefs. /li /ul /lilibQuality Event Support Documentation /bulliProvide technical input to deviations/investigations/CAPAs with Quality, ensuring high‑quality, timely closure. /liliMaintain inspection‑ready documentation and knowledge management for assigned CMO scope. /liliProduce deliverables such as technical narratives, evidence packages, and knowledge repositories. /li /ul /li /ulh3Required Qualifications /h3ulliBS+ in Engineering / Life Science (or related). /lili10–12 years MSAT / process engineering / CMC API support with external site readiness delivery. /liliDemonstrated partner‑facing technical leadership and issue management. /li /ulh3Preferred Qualifications /h3ulliExperience in pharmaceutical/biotech supporting CMO audits/inspections and regulatory responses. /liliMulti‑site/partner oversight experience. /li /ulh3Key Competencies /h3ulliCMO‑facing technical oversight, governance routines, and performance monitoring; issue triage and closure discipline. /liliTech transfer execution, readiness tracking, milestone governance, dependency, and risk management. /liliDeviation/investigation/CAPA technical support, root‑cause rigor and prevention focus in partner settings. /liliChange impact assessment and control strategy awareness, inspection‑ready documentation, and knowledge management. /liliCross‑functional leadership, escalation, and executive‑ready technical risk/decision communication. /li /ulh3Legal and Employment /h3pApplicants 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. /ph3Equal Opportunity EEO /h3pMadrigal is committed to fostering an inclusive and diverse workplace and does 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 /p #J-18808-Ljbffr
