Senior Drug Product SME & CMC Leader (Equity)

Madrigal; Conshohocken (Montgomery County); On-site; USD 174,000 - 200,000; Full time

Benefits offered by this job

Base salary + bonus

Equity

Comprehensive benefits

Flexible PTO

Medical, dental, vision

401(k)

Job summary

Madrigal seeks an Associate Director Drug Product SME to lead drug product formulation and process development for a clinical-stage MASH program. You will guide cross-functional teams, align development with regulatory expectations, and manage external partners to support preclinical through clinical supply.

The role requires a PhD or equivalent in Pharmaceutical Sciences with 10+ years in CMC leadership, strong leadership, and a track record of delivering robust development strategies in a

Qualifications

• PhD in Pharmaceutics, Chemistry or Material Sciences, or BS/MS with commensurate Pharmaceutical Science development and leadership experience.
• 10+ years in Pharmaceutical Science and CMC leadership within biopharma.
• Proven experience with CDMO/CDRO outsourcing, development to commercial manufacturing and regulatory readiness.

Responsibilities

• Lead drug product development deliverables translating strategy into protocols, data packages, and external deliverables.
• Oversee phase-appropriate formulation development, processes, and material supply from preclinical to clinical development.
• Manage CDMO/CRO relationships, including oversight of protocols, batch records, reports, investigations and technical documents.
• Apply Quality-by-Design and Risk Management to development lifecycle and regulatory submissions.

Skills

CMC leadership

Small molecule formulation

CDMO oversight

Regulatory strategy

Cross-functional leadership

Quality/regulatory documentation

Process validation

Risk management

Mentoring

Strategic thinking

Education

PhD in Pharmaceutics, Chemistry or Material Sciences

Job description

Madrigal seeks an Associate Director Drug Product SME to lead drug product formulation and process development for a clinical-stage MASH program. You will guide cross-functional teams, align development with regulatory expectations, and manage external partners to support preclinical through clinical supply.

The role requires a PhD or equivalent in Pharmaceutical Sciences with 10+ years in CMC leadership, strong leadership, and a track record of delivering robust development strategies in a