Associate Director of Manufacturing Science and Technology

Summary

Join Madrigal, a biopharmaceutical company focused on NASH therapeutics, as an Associate Director/Director of Manufacturing Science and Technology (MSAT). This remote position leads the technical strategy and implementation of processes supporting large-scale manufacturing. You will collaborate with cross-functional teams, ensuring regulatory compliance and operational excellence. Responsibilities include technology transfer, process optimization, and troubleshooting. The ideal candidate possesses a strong background in pharmaceutical manufacturing, proven leadership skills, and deep knowledge of cGMP and FDA regulations. Competitive compensation includes a base salary, bonus potential, equity, and comprehensive benefits.

Requirements

• 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%)

Responsibilities

• Work 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

Benefits

• Flexible paid time off (PTO)
• Medical, dental, vision, and life and disability insurance
• Bonus
• Equity