Madrigal Pharmaceuticals

Madrigal Pharmaceuticals

Manager, Product Technical Knowledge Specialist (MSAT)

PA - Conshohocken - Office, USA · Full-time

Sponsorship not specified$140k-$172kDetected 27 days ago
Product ManagementSupply ChainProcess ImprovementCompensationCustomer SupportGMPFDA RegulatoryCommunicationCollaboration

About the role

  • This role is responsible for maintaining deep technical understanding of product formulation, process, and manufacturing controls, and for ensuring continuity of product knowledge across development, manufacturing sites, and lifecycle activities.

Responsibilities

  • Develop and maintain comprehensive technical knowledge of assigned products, including formulation, process design, critical process parameters (CPPs), critical quality attributes (CQAs), and control strategies
  • Develops and maintains the product's technical dossier-including process, analytical methods, controls, and key risks-serving as the single source of truth for MSAT execution.
  • Support interpretation and application of product knowledge to manufacturing operations and process improvements
  • Technology Transfer & Site Support
  • Support technology transfer to external CMOs by authoring, reviewing, and maintaining comprehensive technical transfer and process documentation, ensuring accurate and consistent knowledge transfer from development teams or prior manufacturers
  • Develop and curate CMO-facing knowledge transfer packages (e.g., process descriptions, technical summaries, manufacturing requirements) to support site readiness and technical alignment
  • Provide documentation-based technical support for CMO onboarding and process introduction activities by ensuring completeness, accuracy, and traceability of technical content supporting commercial manufacturing.
  • Leads knowledge gap assessments for tech transfer and launch readiness, and drives closure plans in collaboration with CMC, Quality, and site/CMO partners.
  • Support product lifecycle activities, including post-approval changes, process optimization, continuous improvement, and deviation investigations
  • Collaborate with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC to ensure consistent product understanding

Requirements

  • Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline
  • Minimum of 8 years experience, 3-5 years of experience in MSAT, process engineering, manufacturing support, or pharmaceutical technical operations
  • Working knowledge of GMP manufacturing environments

Nice to have

  • Experience supporting technology transfer activities
  • Familiarity with biologics or small-molecule manufacturing (as applicable)
  • Experience contributing to deviation investigations, change controls, or process improvements
  • Strong technical documentation and knowledge management skills
  • Strong technical and analytical skills
  • Ability to synthesize complex technical information and apply it to manufacturing scenarios
  • Effective cross-functional communication in a regulated environment
  • Attention to detail and commitment to compliance

Compensation

  • Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity.

Company info

  • 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.
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