Associate Director of Manufacturing Science and Technology - Madrigalpharma : Job Details

Associate Director of Manufacturing Science and Technology

Madrigalpharma

Job Location : all cities,MS, USA

Posted on : 2025-03-03T14:15:57Z

Job Description :

About Madrigal:Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Role Overview:Associate Director of Manufacturing Science and Technology (MSAT)The Associate Director/Director of Manufacturing Science and Technology (MSAT) is responsible for leading the technical strategy and overseeing the implementation of scientific, technological, and operational processes in support of large-scale manufacturing operations. This role is integral in driving continuous improvement, ensuring production process optimization, and guiding technology transfers to enable efficient, high-quality manufacturing of pharmaceutical products (or applicable industry products).This is a Remote position.

Position Responsibilities:

  • Works with management to plan and execute the MSAT department strategy for technology transfer from process development through to commercial manufacturing at external partners.
  • Serve as the technical expert for Drug Substance and Drug Product manufacturing processes and provide guidance on problem-solving, process deviation resolution, and process optimization.
  • Support external partner facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
  • Oversee process robustness monitoring and data analytics (modeling/trending) to identify opportunities for process optimization, cost reduction, and yield improvement.
  • Travel will be required to support person-in-plant activities during production campaigns.
  • Work closely internally with Quality Assurance and Regulatory teams to ensure that all manufacturing processes comply with GMP, FDA, and other applicable regulatory requirements.
  • Collaborate with R&D on development projects and/or process versions to ensure manufacturability, scalability, and process consistency.

    • Qualifications and Skills Required:

  • BS, MS, or PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field alongside 8-10 years of work experience.
  • Proven track record of managing large-scale manufacturing operations, leading technology transfers from R&D to manufacturing, and troubleshooting of manufacturing processes.
  • Broad experience in all process areas: Drug Substance, Drug Product and Packaging.
  • Experience leading and/or interacting with GMP manufacturing, process validation, and tech transfer teams.
  • Ability to communicate effectively across all levels of the organization and with external partners.
  • Deep knowledge of cGMP, FDA regulations, and other global regulatory standards.
  • Proficiency in using statistical process control (SPC), Lean, Six Sigma, or other continuous improvement methodologies.
  • Domestic and/or international travel required (10-20%).

    • Compensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

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    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.

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