Senior Drug Product SME Lead, CMC & Formulation

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

Benefits offered by this job

Equity

Comprehensive benefits package

Flexible paid time off

Medical, dental, vision, lifeinsurance

401(k)

Job summary

Madrigal Pharmaceuticals in the United States is seeking an Associate Director, Drug Product SME to advance the CMC development of Madrigal’s small‑molecule portfolio, ensuring preclinical and clinical studies are supported with phase‑appropriate, quality drug product deliverables.

You will lead cross‑functional teams, oversee CDMO/CRO relationships, and drive regulatory, quality, and risk management activities while mentoring a high‑performing pharmaceutical science group in Technical

Qualifications

• PhD or equivalent with leadership in Pharmaceutical Science and CMC.
• Minimum of 10 years of pharmaceutical science and CMC leadership experience.
• Experience with CDMO/CRO management and regulatory documentation.
• Strong knowledge of cGMP, ICH guidelines, and regulatory requirements.

Responsibilities

• Lead or oversee drug product formulation and process development from preclinical through clinical stages.
• Manage CDMO/CRO relationships and oversee key deliverables and investigations.
• Drive quality by design and risk management across development lifecycle.
• Collaborate with Quality, Regulatory, MSAT, and Supply Chain to align development with program goals.

Skills

Strategic leadership

People leadership

Problem solving

Communication skills

Education

PhD degree in Pharmaceutics, Chemistry or Material Sciences, or BS/MS degree

Job description

Madrigal Pharmaceuticals in the United States is seeking an Associate Director, Drug Product SME to advance the CMC development of Madrigal’s small‑molecule portfolio, ensuring preclinical and clinical studies are supported with phase‑appropriate, quality drug product deliverables.

You will lead cross‑functional teams, oversee CDMO/CRO relationships, and drive regulatory, quality, and risk management activities while mentoring a high‑performing pharmaceutical science group in Technical