StellenbeschreibungppMadrigal 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. /ph3Key Responsibilities /h3ulliExecute GMP batch disposition and release for active pharmaceutical ingredients (APIs) and intermediates to ensure timely, compliant, well‑documented release decisions supporting commercial supply. /liliReview and disposition API batch records, CoFA and quality documentation from external CMOs/CDMOs against approved specifications and the Quality Management System. /liliCoordinate resolution of release‑blocking deviations, OOS/OOT investigations, and documentation gaps with manufacturing partners and internal stakeholders. /liliMaintain accurate, inspection‑ready release records and contribute to cycle‑time and right‑first‑time improvements for the API release workflow. /liliOperate with documentation rigor, traceable decision rationales, and clear escalation discipline. /liliTrack and report API release cycle time, backlog, and RFT metrics; drive right‑first‑time improvements with partners. /liliPartner with MSAT, Supply Chain, and Regulatory on release priorities, supply continuity, and timeline mitigation. /liliSupport change controls impacting API release (specifications, methods, supplier changes) with timely assessment. /liliMaintain inspection‑ready release evidence packages and support audit/inspection responses for API operations. /liliEscalate quality concerns, recurring documentation errors, or supply‑impacting risks with clear options and rationale. /liliContribute to SOPs, work instructions, and release checklists for API disposition processes. /liliSupport continuous improvement of release workflows and partner documentation quality. /li /ulh3Required Qualifications /h3ulliBS in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related). /lili5‑7 years of GMP pharmaceutical/biotech experience including hands‑on batch record review and disposition. /liliDemonstrated experience reviewing API or drug product batch documentation from external CMOs. /liliStrong knowledge of GMP requirements, ICH Q7, and FDA/EMA expectations for batch release. /liliStrong documentation discipline, attention to detail, and risk‑based judgment. /li /ulh3Preferred Qualifications /h3ulliExperience with API and intermediate disposition, including small molecule and/or oligonucleotide manufacturing. /liliExperience with Veeva Vault Quality (eQMS) batch disposition workflow. /liliExperience supporting health authority inspections with batch disposition narratives and evidence. /liliExperience reviewing deviation and OOS/OOT investigations. /li /ulh3Key Competencies /h3ulliBatch record review and disposition discipline, documentation rigor, and decision rationale traceability. /liliRisk‑based judgment for release decisions, deviation impact assessment, and escalation discipline. /liliPartner coordination with external CMOs for documentation quality and timely issue resolution. /liliCycle‑time and right‑first‑time focus, backlog management, and metrics‑driven execution. /liliInspection readiness mindset, evidence retrieval readiness, and audit narrative support. /liliCross‑functional coordination across MSAT, Supply Chain, and Regulatory for release priorities. /liliVeeva Vault Quality (eQMS) proficiency to execute batch disposition workflows and maintain inspection‑ready records. /li /ulh3Equal Opportunity and Data Privacy Statement /h3pWe 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. Join our growing team focused on transforming the treatment of people with liver diseases. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. /p /p #J-18808-Ljbffr
