Manager, Product Technical Knowledge Specialist (MSAT)
Madrigal Pharmaceuticals
June 30, 2026
Remote friendly (Conshohocken, PA)
United States
Operations
Position Summary
- The Manager, Product Technical Knowledge Specialist (MSAT) serves as a technical subject matter expert for assigned small molecule pharmaceutical products, supporting the full product lifecycle from technology transfer through commercial manufacturing and post-approval changes. Own and manage MSAT technical documentation and knowledge transfer materials supporting manufacturing performed at external CMOs.
Key Responsibilities
Product & Process Technical Knowledge
- Develop and maintain technical knowledge (formulation, process design, CPPs, CQAs, control strategies).
- Maintain the technical dossier (process, analytical methods, controls, key risks) as the MSAT single source of truth.
- Act as technical knowledge owner for product/process requirements.
- Support interpretation/application of product knowledge to manufacturing operations and process improvements.
Technology Transfer & Site Support
- Author/review/maintain technology transfer and process documentation for external CMOs.
- Create CMO-facing knowledge transfer packages (e.g., process descriptions, technical summaries, manufacturing requirements).
- Provide documentation-based technical support for CMO onboarding and process introduction.
- Lead knowledge gap assessments for tech transfer and launch readiness; drive closure plans.
Lifecycle Management
- Support post-approval changes, process optimization, continuous improvement, and deviation investigations.
- Contribute to technical assessments related to change control, CAPAs, and manufacturing investigations.
- Assess technical impact of raw material, equipment, or process updates.
Cross-Functional Collaboration & Documentation
- Partner with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC.
- Serve as technical liaison to manufacturing sites.
- Support inspection readiness through documented, traceable knowledge.
- Contribute to/review technical documents; maintain knowledge repositories and GMP-aligned documentation.
Required Qualifications
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.
- 8+ years experience; 3–5 years in MSAT, process engineering, manufacturing support, or pharmaceutical technical operations.
- Working knowledge of GMP manufacturing environments.
- Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support.
Preferred Qualifications
- Technology transfer experience.
- Familiarity with biologics or small-molecule manufacturing.
- Experience with deviation investigations, change controls, or process improvements.
- Strong technical documentation and knowledge management skills.
Key Competencies
- Strong technical/analytical skills; ability to synthesize complex information.
- Cross-functional communication in a regulated environment.
- Attention to detail and commitment to compliance.
- Ability to work independently in a matrixed team.
Location & Travel
- US Hybrid; ~5–10% travel to manufacturing sites.
Benefits
- Eligible for comprehensive benefits: flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional/Roth/match). Additional voluntary benefits incl. supplemental life and legal services; Employee Assistance Program.
Application Instructions
- Apply via Madrigal Careers site; applications accepted on an ongoing basis.
- The Manager, Product Technical Knowledge Specialist (MSAT) serves as a technical subject matter expert for assigned small molecule pharmaceutical products, supporting the full product lifecycle from technology transfer through commercial manufacturing and post-approval changes. Own and manage MSAT technical documentation and knowledge transfer materials supporting manufacturing performed at external CMOs.
Key Responsibilities
Product & Process Technical Knowledge
- Develop and maintain technical knowledge (formulation, process design, CPPs, CQAs, control strategies).
- Maintain the technical dossier (process, analytical methods, controls, key risks) as the MSAT single source of truth.
- Act as technical knowledge owner for product/process requirements.
- Support interpretation/application of product knowledge to manufacturing operations and process improvements.
Technology Transfer & Site Support
- Author/review/maintain technology transfer and process documentation for external CMOs.
- Create CMO-facing knowledge transfer packages (e.g., process descriptions, technical summaries, manufacturing requirements).
- Provide documentation-based technical support for CMO onboarding and process introduction.
- Lead knowledge gap assessments for tech transfer and launch readiness; drive closure plans.
Lifecycle Management
- Support post-approval changes, process optimization, continuous improvement, and deviation investigations.
- Contribute to technical assessments related to change control, CAPAs, and manufacturing investigations.
- Assess technical impact of raw material, equipment, or process updates.
Cross-Functional Collaboration & Documentation
- Partner with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC.
- Serve as technical liaison to manufacturing sites.
- Support inspection readiness through documented, traceable knowledge.
- Contribute to/review technical documents; maintain knowledge repositories and GMP-aligned documentation.
Required Qualifications
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related field.
- 8+ years experience; 3–5 years in MSAT, process engineering, manufacturing support, or pharmaceutical technical operations.
- Working knowledge of GMP manufacturing environments.
- Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support.
Preferred Qualifications
- Technology transfer experience.
- Familiarity with biologics or small-molecule manufacturing.
- Experience with deviation investigations, change controls, or process improvements.
- Strong technical documentation and knowledge management skills.
Key Competencies
- Strong technical/analytical skills; ability to synthesize complex information.
- Cross-functional communication in a regulated environment.
- Attention to detail and commitment to compliance.
- Ability to work independently in a matrixed team.
Location & Travel
- US Hybrid; ~5–10% travel to manufacturing sites.
Benefits
- Eligible for comprehensive benefits: flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) (traditional/Roth/match). Additional voluntary benefits incl. supplemental life and legal services; Employee Assistance Program.
Application Instructions
- Apply via Madrigal Careers site; applications accepted on an ongoing basis.