Head of DS & Process Chemistry & Tech Transfer

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 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