Senior Manager, External Manufacturing - 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 pThe Senior Manager, API External Manufacturing Lead is responsible for supporting API manufacturing execution, performance monitoring, and supply continuity across Madrigal’s external API manufacturing network. This role serves as the primary operational liaison for assigned API CMOs, ensuring approved supply plans are translated into executable manufacturing activities and that production, release, and delivery milestones are achieved. /p pThe role leads the day-to-day activities of the API Virtual Plant Team, coordinating cross-functional Madrigal SMEs across MSAT, CMC, Quality, Regulatory, Procurement, Planning, and Finance to monitor performance, resolve operational constraints, and support readiness for key manufacturing and lifecycle milestones. This position manages API CMO governance activities, performance tracking, issue escalation, recovery planning, and execution-related risk management. /p pIn partnership with Procurement, MSAT, CMC, Quality, and Planning, this role supports the ongoing development and optimization of the API manufacturing network, including onboarding and qualification activities for new API vendors to improve supply reliability, flexibility, and long-term network resilience. /p h3Key Responsibilities /h3 h3Manufacturing Performance Supply Continuity /h3 ul liMonitor API manufacturing performance across assigned CMOs through established KPIs, governance processes, and routine performance reviews. /li liEnsure execution alignment to approved demand and supply plans by tracking capacity, inventory levels, and key planning assumptions. /li liSupport API continuity planning activities by identifying risks and coordinating mitigation actions with internal and external stakeholders. /li liMaintain visibility of manufacturing performance through scorecards, capacity reviews, and continuity planning updates b. /b /li /ul h3Issue Management Recovery Execution /h3 ul liCoordinate resolution of API supply constraints, including capacity limitations, material shortages, and quality-related events, working closely with CMOs and internal stakeholders. /li liDevelop and track recovery plans, ensuring timely execution of corrective actions and escalation of critical issues. /li liCommunicate recovery options, timelines, and associated trade-offs to management and cross-functional teams. /li liMaintain issue logs, recovery plans, and escalation documentation to support effective decision-making. /li /ul h3External Manufacturing Oversight – Virtual Plant Team /h3 ul liLead cross-functional coordination activities supporting API manufacturing execution and milestone readiness. /li liPartner with MSAT, CMC, and Quality to support tech transfers, deviations, investigations, and change management activities. /li liFacilitate routine governance meetings and performance reviews with CMOs and internal stakeholders. /li liDevelop and maintain readiness trackers, action registers, and cross-functional dependency plans to support reliable execution. /li /ul h3Quality Compliance Support /h3 ul liPartner with Quality and MSAT to support deviation management, disposition activities, and compliance-related initiatives impacting supply execution. /li liSupport inspection readiness efforts through maintenance of appropriate documentation and execution records. /li liContribute to development of readiness packages, governance materials, and audit-support documentation as needed. /li /ul h3Required Qualifications /h3 ul liBS or higher degree in Supply Chain, Engineering, Science, or related field. /li li7-10 years of experience in pharmaceutical or biotechnology manufacturing, external supply management, or API operations within an outsourced manufacturing environment. /li liExperience supporting API manufacturing performance management, including CMO oversight, issue resolution, and execution of recovery plans. /li liDemonstrated ability to work effectively across MSAT, CMC, Quality, Planning, Procurement, and external manufacturing partners b. /b /li /ul h3Preferred Qualifications /h3 ul liExperience in pharmaceutical or biotechnology API manufacturing within a multi-CMO outsourced network. /li liExperience supporting commercial supply, product launches, or lifecycle management initiatives. /li liFamiliarity with long lead-time materials, campaign manufacturing, capacity planning, and supply constraint management. /li /ul h3Key Competencies /h3 ul liAPI Manufacturing Execution Performance Management /li liAbility to monitor API manufacturing performance, support governance processes, and drive execution against supply commitments. /li liIssue Resolution Recovery Coordination /li liAbility to identify operational risks, coordinate recovery activities, and facilitate timely resolution of manufacturing constraints. /li liCross-Functional Collaboration /li liStrong ability to collaborate across MSAT, CMC, Quality, Planning, Procurement, and external partners to achieve business objectives. /li liQuality Technical Partnership /li liEffective partnership with Quality and MSAT teams to support deviations, change controls, tech transfers, and manufacturing readiness activities. /li liOperational Excellence Execution Discipline /li liStrong organizational skills, attention to detail, and ability to maintain governance processes, documentation, and execution tracking mechanisms. /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