Executive Director, Chemical Process R&D

Madrigal; Conshohocken (Montgomery County); On-site; USD 276,000 - 329,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Paid time off

401(k) with employer match

Mental health support

Job summary

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The role focuses on defining DS route and RSM strategy, tech transfer, and cross-functional collaboration to support clinical supply and lifecycle readiness.

The successful candidate will bring 18+ years of process chemistry/DS development experience, with leadership in route development, impurity strategy, and external manufacturing partnerships.

Qualifications

• BS+ in Chemistry or related field; PhD preferred.
• 18+ years process chemistry/DS development with external manufacturing experience.
• Proven leadership of route development, impurity strategy, and tech transfer.
• Strong technical writing and cross-functional leadership.

Responsibilities

• Define DS route and RSM strategy aligned with phase-appropriate control strategy.
• 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).
• Partner with Analytical on method needs for process characterization and control strategy.
• Partner with Engineering on scale-up, safety, and equipment/process suitability.

Skills

process chemistry

DS development

tech transfer

external manufacturing

leadership

technical writing

cross-functional collaboration

Education

BS+ in Chemistry or related field

PhD preferred

Job description

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

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

Benefits

• 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.
• 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.

Equal Opportunity and Diversity

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

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. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact [e-mail].