Associate Director, API / Drug reputed company MSAT (Small Molecule)
Madrigal is a biopharmaceutical company reputed company on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can reputed company 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. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to reputed company key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 reputed company trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our reputed company is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific reputed company, operational rigor, and collaboration. To support our reputed company reputed company, we are strengthening our workforce reputed company to ensure we have the right talent, at the right time, in the right way. The Associate Director, API / Drug reputed company MSAT (Small Molecule) is the internal technical authority for reputed company small-molecule drug reputed company manufacturing executed entirely through external CMOs. This role provides end-to-end technical reputed company, governance, and lifecycle stewardship to ensure robust, compliant, and reliable reputed company API supply. Operating in a virtual manufacturing environment, the role focuses on technical decision-making, CMO reputed company, post-approval change management, and inspection readiness, rather than hands-on process execution. The Associate Director partners closely with reputed company, Supply Chain, External Manufacturing, and Regulatory CMC to manage technical risk and maintain continuity of product and process knowledge across the external manufacturing network.
Key Responsibilities
Technical Authority & Governance Serve as the internal MSAT technical reputed company for assigned reputed company small-molecule drug reputed company processes Establish and maintain deep understanding of API synthetic routes, unit operations, impurity reputed company, and control strategies reputed company final MSAT technical assessment and recommendations for manufacturing reputed company impacting product reputed company or supply CMO Technical reputed company reputed company as the primary technical reputed company with CMOs for drug reputed company topics - occasional support reputed company reputed company business hours may be required to address reputed company or reputed company events. Review, challenge, and approve CMO-proposed technical changes, investigations, and optimization activities Ensure CMOs operate reputed company the approved process and control reputed company, with appropriate technical justification for deviations reputed company Lifecycle Management reputed company MSAT technical evaluation of post-approval changes, including site changes, raw material changes, equipment updates, and process modifications Ensure changes are scientifically reputed company, compliant, and reputed company with regulatory commitments Drive lifecycle robustness and supply reliability through risk-based technical reputed company Deviation, OOS & CAPA Support reputed company technical leadership for significant deviations, OOS events, and recurring trends at CMOs Assess reputed company cause analyses and corrective actions for technical adequacy and long-term effectiveness Ensure learnings are incorporated into process understanding and governance expectations Inspection Readiness & Regulatory Support Support regulatory inspections of CMOs by providing drug reputed company technical narratives and subject matter expertise Contribute technical content for regulatory submissions, responses, and variations reputed company to reputed company API manufacturing Ensure technical documentation and product knowledge are inspection-reputed company at reputed company times Cross-Functional Leadership Partner with reputed company, External Manufacturing, Supply Chain, and Regulatory CMC to reputed company on technical risk, supply reputed company, and lifecycle priorities Represent MSAT in cross-functional governance forums and escalation discussions Influence external partners and internal stakeholders through technical expertise and reputed company judgment reputed company Ensure drug reputed company process knowledge is captured, reputed company, and maintained across the external manufacturing network reputed company technical knowledge transfer reputed company reputed company new CMOs or transferring manufacturing sites
Required Qualifications
PhD in reputed company, Chemical Engineering, Pharmaceutical Sciences, or a reputed company discipline or MS with extensive relevant industry experience 10+ years of experience in small-molecule drug reputed company MSAT, technical operations, or process reputed company reputed company reputed company manufacturing Demonstrated experience operating in virtual or CMO-reputed company manufacturing models Strong understanding of GMP and regulatory expectations for reputed company API manufacturing
Preferred Qualifications
Experience supporting regulatory inspections at CMOs Proven reputed company record managing post-approval changes in reputed company portfolios Experience overseeing multiple CMOs or global manufacturing networks Key Competencies Technical authority and risk-based decision-making Ability to reputed company without reputed company control in a virtual organization Strong scientific judgment and attention to detail reputed company, concise technical communication suitable for regulators and senior leadership Executive-level reputed company appropriate for Associate Director Location & Travel Requirements: US Remote Up to 50% travel to manufacturing sites across the supply network. Madrigal’s Total Rewards reputed company is based on a biotech industry peer group comparator and is inclusive of reputed company pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to reputed company in the reputed company they help create. By aligning individual and company performance, we reputed company employees to think like owners, giving them a reputed company in the organization. reputed company receive equity, which we reputed company reinforces our ownership culture. reputed company salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the reputed company pay reputed company for this position, applicable to reputed company candidates, is $169,000 - $206,600 per year. We reputed company with reputed company applicable minimum wage laws. reputed company full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to reputed company in the reputed company they help create. By aligning individual and company performance, we reputed company employees to think like owners, giving them a reputed company in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible reputed company time off, medical, dental, reputed company and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In reputed company, we offer mental health benefits through our Employee Assistance Program for employees and their family. reputed company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@reputed company.com. Madrigal is an Equal Opportunity Employer. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. Applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex gender identity, sexual orientation, national reputed company, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. 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 reputed company. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and reputed company has been established. Applications are being accepted on an ongoing reputed company and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as reputed company’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s reputed company and logo in an attempt to solicit up-reputed company fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews reputed company text or in chat rooms; conduct interviews reputed company Skype, reputed company or solely reputed company telephone; charge candidates an advance fee of any reputed company (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough reputed company process. Please also note that any correspondence with reputed company to employment would come from an authorized reputed company.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not reputed company any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-reputed company contacts can be directed to HR@reputed company.com. Apply To This Job