Senior Manager, MSAT Product Knowledge Steward

Position Summary

The Senior Manager, MSAT Product Knowledge Steward is the scientific steward for assigned small-molecule pharmaceutical products, serving as the technical subject matter expert responsible for preserving, integrating, and communicating product knowledge spanning drug substance, drug product and finished goods across the entire product lifecycle-from process development through technology transfer, commercial manufacturing, and post-approval lifecycle management.

The ideal candidate is an experienced Process Development scientist who enjoys organizing complex technical knowledge as much as generating it. This role combines deep scientific expertise with product knowledge stewardship, ensuring critical manufacturing, process, and control strategy knowledge is captured, maintained, and translated into high-quality technical documentation and guidance that enables successful technology transfer and commercial manufacturing.

Key Responsibilities

Product & Process Technical Knowledge

• Develop and maintain comprehensive technical knowledge of assigned products, including formulation, process design, critical process parameters (CPPs), critical quality attributes (CQAs), and control strategies
• Coordinate technical experts across functions in capturing product knowledge

• 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
• Act as a technical knowledge owner for products within MSAT, ensuring accurate and current understanding of product and process requirements
• 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

Lifecycle Management

• Support product lifecycle activities, including post-approval changes, process optimization, continuous improvement, and deviation investigations
• Contribute technical assessments related to change control, CAPAs, and manufacturing investigations
• Assist in evaluating the technical impact of raw material changes, equipment changes, or process updates

Cross-Functional Collaboration

• Collaborate with Manufacturing, Process Engineering, Quality, Supply Chain, and Regulatory CMC to ensure consistent product understanding
• Serve as a technical liaison between MSAT and manufacturing sites for product-specific topics
• Support inspection readiness by ensuring technical product knowledge is documented and traceable

Documentation & Knowledge Management

• Author and maintain comprehensive product knowledge packages that consolidate development history, process rationale, technical risks, control strategies, and manufacturing knowledge into a single source of truth supporting MSAT execution and technology transfer.
• Ensure technical documentation aligns with GMP expectations and internal standards
• Contribute to or review technical documents such as process descriptions, technical reports, risk assessments, and knowledge summaries

Required Qualifications

• MS or PhD in Chemistry (preferred) or Bachelor's in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum of 7 years of relevant pharmaceutical industry experience, including at least 3-5 years in small-molecule process development, API MSAT, manufacturing science, technical operations, or commercial manufacturing support.
• Working knowledge of GMP manufacturing environments
• Demonstrated understanding of pharmaceutical manufacturing processes and lifecycle support
• Demonstrated hands on experience supporting late-stage development, technology transfer, process validation, commercial launch, or lifecycle management of small-molecule drug substance/API processes

Preferred Qualifications

• Experience supporting technology transfer activities
• Experience contributing to deviation investigations, change controls, or process improvements
• Strong technical documentation and knowledge management skills

Key Competencies

• 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
• Ability to work independently while contributing as part of a matrixed team
• Deep scientific curiosity combined with a passion for organizing, documenting and preserving complex API process knowledge while serving as the long-term technical steward for commercial products.

Madrigal's 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 candidate's 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 $156,000 - $184,000 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 offerings. In 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.