Director, Drug Product SME — CMC for siRNA/Small Molecules

Madrigal; Conshohocken (Montgomery County); On-site; USD 204,000 - 249,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with match

Mental health benefits

Job summary

Madrigal is seeking a Director, Drug Product SME to lead CMC and drug product development for siRNA/oligonucleotide and small-molecule portfolios. You will coordinate with external CDMOs/CROs, guide regulatory submissions, and ensure clinical supply readiness across preclinical to early clinical phases.

The role requires deep expertise in CMC, QA, and cross-functional collaboration within Technical Operations, Regulatory Affairs, and Supply Chain, with a focus on advancing a NASH/MASH-focused

Qualifications

• Education: PhD in Pharmaceutics, Chemistry or Material Sciences, or BS/MS with commensurate development/leadership experience.
• 15+ years in Pharmaceutical Science and CMC leadership in biopharma.
• Strong experience with siRNA/oligonucleotide drug product formulation/process development; external CDMO/CRO oversight.

Responsibilities

• Lead phase-appropriate development of siRNA/oligonucleotide and small-molecule formulations and processes.
• Oversee CDMO/CRO interactions; ensure readiness for clinical supply manufacture and scale-up.
• Develop regulatory documentation, risk assessments, and CMC strategy with QA and regulatory teams.
• Drive cross-functional leadership across Technical Operations, Quality, Regulatory, and Supply Chain.

Skills

CMC leadership

siRNA/oligonucleotide

Drug product formulation

Process development

CDMO oversight

Regulatory filing

Leadership

Education

PhD in Pharmaceutics or Chemistry

BS/MS in Pharmaceutical Science

Job description

Madrigal is seeking a Director, Drug Product SME to lead CMC and drug product development for siRNA/oligonucleotide and small-molecule portfolios. You will coordinate with external CDMOs/CROs, guide regulatory submissions, and ensure clinical supply readiness across preclinical to early clinical phases.

The role requires deep expertise in CMC, QA, and cross-functional collaboration within Technical Operations, Regulatory Affairs, and Supply Chain, with a focus on advancing a NASH/MASH-focused