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Associate Director, Manufacturing Technical Project Management (MSAT)

$174.13k - $199.62k
Full-time

Madrigal Pharmaceuticals

Madrigal 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.

Madrigals medication Rezdiffra (resmetirom) is a once-daily oral liver-directed THR-β agonist designed to target 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 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

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.

The Manufacturing Technical Project Manager (MSAT) is responsible for leading and coordinating technical projects supporting commercial pharmaceutical manufacturing executed primarily through external contract manufacturing organizations (CMOs). The role serves as the MSAT project lead for drug substance (API)focused initiatives while also supporting end-to-end CMC projects spanning drug substance drug product and supply readiness as required.

Operating within MSAT the role ensures cross-functional alignment disciplined execution and timely delivery of technical objectives related to technology transfer lifecycle changes and manufacturing readiness. The position works closely with MSAT technical SMEs Quality Supply Chain Regulatory CMC and external partners and does not own commercial regulatory strategy or medical activities. The role will lead a team of internal and/or contingent resources and will progressively assume responsibility for building managing and developing a team of MSAT project management professionals as the organization scales.

Key Responsibilities

Technical Project Leadership

  • Lead MSAT technical projects supporting commercial manufacturing with primary focus on drug substance (API) activities at external CMOs
  • Develop and manage integrated project plans timelines and deliverables for technical initiatives
  • Drive execution of MSAT-owned activities while coordinating inputs from cross-functional stakeholders

Team Leadership & Resource Management

  • Lead and develop a blended team of MSAT project managers covering both internal and contingent resources as the organization scales
  • Own delivery coordination of all MSAT-led programs including work allocation deliverable quality performance expectations and integration with internal teams
  • Establish clear roles responsibilities objectives and development priorities for team members and allocate resources across the MSAT project portfolio based on technical complexity business priority capacity and project timing
  • Provide coaching and feedback to team members and help develop the organizations future MSAT project-management capabilities

CMO-Focused Project Management

  • Serve as the primary MSAT project interface with CMOs for assigned initiatives
  • Coordinate technical deliverables timelines and dependencies with external manufacturing partners
  • Facilitate regular project reviews risk discussions and issue resolution with CMOs

Drug Substance / API Project Scope

  • Manage projects related to API technology transfer process changes site onboarding and manufacturing readiness
  • Coordinate MSAT technical inputs for investigations process improvements and lifecycle initiatives affecting drug substance manufacturing
  • Ensure alignment between CMO execution and approved process understanding and control strategy

End-to-End CMC Project Support

  • Lead or support integrated CMC projects spanning drug substance (DS) drug product (DP) and supply chain readiness as needed
  • Coordinate handoffs and dependencies across DS DP Quality Regulatory CMC and Supply Chain teams
  • Maintain visibility into cross-functional risks and mitigation plans impacting overall project timelines

Risk Issue & Change Management

  • Identify track and escalate technical and execution risks related to manufacturing projects
  • Support management of project-related changes including scope timelines and technical dependencies
  • Ensure issues are documented communicated and resolved through appropriate governance channels

Communication & Governance

  • Prepare and deliver clear project updates to MSAT leadership and cross-functional teams
  • Support project governance forums decision tracking and documentation
  • Ensure project execution aligns with GMP requirements and internal MSAT standards

Required Qualifications

  • Bachelors degree in Engineering Chemistry Pharmaceutical Sciences or a related technical discipline
  • 10-12 years of experience in pharmaceutical manufacturing MSAT technical operations or technical project management
  • Demonstrated experience managing projects involving external CMOs
  • Strong understanding of pharmaceutical manufacturing processes preferably drug substance (API)

Preferred Qualifications

  • Experience supporting small-molecule drug substance manufacturing
  • Experience managing end-to-end CMC or technical operations projects
  • Familiarity with GMP environments and regulated project execution
  • Experience building or managing technical project-management or matrixed teams in a pharmaceutical or other regulated environment
  • PMP or equivalent project management certification (a plus not required)

Key Competencies

  • Strong technical project management skills
  • Ability to lead cross-functional teams without direct authority
  • Effective communication with internal stakeholders and external partners
  • Risk-based problem solving and prioritization
  • Attention to detail and execution discipline in regulated environments
  • Ability to scale team capacity delegate effectively coach junior resources and maintain team accountability

Madrigals Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners giving them a stake in the organization.

All employees receive equity which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidates qualifications skills education experience business needs and market demands. As of the date of this posting a good faith estimate of the current pay scale for this position applicable to all candidates is $174134 - $199621 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits including flexible paid time off medical dental vision 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 addition we offer mental health benefits through our Employee Assistance Program for employees and their family. The 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

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.

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.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals Hiring Managers seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigals name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g. fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized 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 open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to .

Required Experience:

Director

Vacancy posted a month ago
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