Full Job Description
Owns analytical development strategy and execution oversight to ensure fit-for-purpose methods and characterization packages support DS/DP decisions, release readiness, and stability programs. Establishes method lifecycle expectations, data integrity standards, and external lab governance to maintain reliable, traceable data. Partners with DS/DP and CMC Strategy to align specifications, reference standards, and analytical rationales within a phase-appropriate control strategy.
Key Responsibilities
• Define analytical strategy and prioritization across assets (release, stability, in-process)
• Ensure method development/qualification plans meet program timelines and decisions
• Govern external analytical execution, data review standards, and issue escalation
• Align specs, reference standards, and analytical justifications with DS/DP strategy
• Ensure analytical sections and rationales are ready for CMC authoring and filings
Required Qualifications
• BS+ in Analytical Chemistry or related (advanced degree preferred)
• 18+ years analytical development experience in regulated environment
• Demonstrated leadership of method strategy, data integrity, and external partner oversight
• Strong cross-functional communication and documentation skills
Preferred Qualifications
• Experience supporting solid-state characterization strategies and polymorph programs
• Experience supporting pharmaceutical regulatory filings and HA responses
Key Competencies
• Analytical method lifecycle management and scientific rigor
• Data integrity mindset and investigation/troubleshooting leadership
• Spec/control strategy alignment and documentation clarity
• Vendor governance and cross-functional influence
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 $276,205 - $328,644 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.