Owns DS process strategy and execution oversight, ensuring synthetic routes, RSM strategy, impurity understanding, and process controls enable scalable, safe, and cost-effective external manufacturing. Leads organic chemistry resources to generate process understanding, robust operating ranges, and tech transfer packages to CDMOs. Partners with Analytical Development and Engineering to align method readiness, process safety, and validation expectations, and ensures DS contributions to CMC documentation are clear and regulator ready.
Key ResponsibilitiesProcess Strategy & Development- Define DS route and RSM strategy aligned with phase-appropriate control strategy
- Approve process R&D plans (optimization, robustness, impurity investigations)
- Ensure DS deliverables support clinical supply builds and lifecycle readiness
Tech Transfer & External Manufacturing Support- Lead DS tech transfer expectations and readiness criteria for CDMOs
- Provide technical oversight for deviations, investigations, CAPA, and change impacts
- Drive continuous improvement initiatives (yield, cycle time, robustness)
Cross-Functional Integration & Documentation- Partner with Analytical on method needs for process characterization and control strategy
- Partner with Engineering on scale-up, safety, and equipment/process suitability
- Provide DS inputs and rationales for CMC documents and health authority responses
Required Qualifications- BS+ in Chemistry or related (PhD preferred)
- 18+ years process chemistry/DS development with external manufacturing support
- Demonstrated leadership of route development, impurity strategy, and tech transfer
- Strong technical writing and cross-functional leadership
Preferred Qualifications- Experience developing RSM strategies and supporting Phase 2 progression
- Experience supporting polymorph/solid-form implications for DS/DP interface
Key Competencies- Synthetic/process chemistry leadership and impurity/control strategy thinking
- Tech transfer and CDMO governance
- Risk assessment, troubleshooting, and decision framing
- High-quality CMC documentation inputs
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.
