Executive Director, Chemical Process R&D
Madrigal Pharmaceuticals
Summary
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.
Job description
Key Responsibilities
Process 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
Requirements
- BS+ in Chemistry or related field
- 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
- Experience developing RSM strategies and supporting Phase 2 progression
- Experience supporting polymorph/solid-form implications for DS/DP interface
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- 401(k) Matching
- Equity
- Bonus
- Flexible PTO
- Mental Health Benefits
- Employee Assistance Program
- Supplemental Life Insurance
- Legal Services
Company overview
Madrigal Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), a serious form of fatty liver disease. The company's lead product, Rezdiffra (resmetirom), is a once-daily, oral thyroid hormone receptor (THR)-β selective agonist that targets key underlying causes of MASH in the liver. Rezdiffra received FDA approval in 2024 as the first treatment for MASH with moderate to advanced liver fibrosis, representing a significant breakthrough in hepatology. Headquartered in Conshohocken, Pennsylvania, Madrigal is publicly traded on NASDAQ under the symbol MDGL. The company continues to advance its clinical development programs, including ongoing Phase 3 trials evaluating Rezdiffra for the treatment of compensated MASH cirrhosis. Madrigal's innovative approach addresses a critical unmet medical need in liver disease therapeutics.