Executive Director, Chemical Process R&D

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

Benefits offered by this job

Equity

Comprehensive benefits

401(k) with employer match

Flexible PTO

Mental health support

Disability insurance

Job summary

Madrigal Pharmaceuticals is seeking a senior-level DS process chemist to define routes, drive tech transfer to CDMOs, and support CMC documentation for regulatory submissions. You will lead cross-functional teams, shape impurity strategies, and ensure robust process development aligned with clinical supply needs.

The role emphasizes external manufacturing collaboration, RSM strategy, and continuous improvement to enable scalable, safe, and cost-effective manufacturing of DS for late-stage

Qualifications

• 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.

Responsibilities

• 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.
• 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.
• Provide DS inputs and rationales for CMC documents and health authority responses.

Skills

Route development leadership

Impurity strategy

Tech transfer

Cross-functional leadership

Technical writing

Education

BS in Chemistry or related (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.

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 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

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.

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

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.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.