VP, CMC – Small Molecule Outsourced Operations

Engage Scientific; Boston (MA); On-site; USD 260,000 - 380,000; Full time

Job summary

Engage Scientific is seeking a Vice President, Head of CMC (Small Molecule) to lead all CMC activities in a fully outsourced model. You will direct drug substance, drug product, analytics, manufacturing, and supply chains, collaborating with regulators and finance to drive late-stage development and lifecycle management.

The role requires 15+ years in pharma/biotech with deep CMC experience, strong leadership, and a track record of successful external partnerships, tech transfer, and NDA/MAA

Qualifications

• MS or PhD in chemistry, chemical engineering, pharmaceutical sciences, or a related discipline.
• 15+ years in pharma or biotech, with at least 5 years leading small molecule CMC, process development, or technical operations.
• Proven track record managing outsourced development and manufacturing through external partners.
• Hands-on experience taking a small molecule from clinical stage through NDA/MAA and launch.
• Direct experience with scale-up, tech transfer, PPQ, validation, and qualifying commercial supply.
• Experience working with FDA and EMA, with strong command of cGMP and ICH expectations.

Responsibilities

• Build and own a CMC strategy from clinical through registration, launch, and lifecycle management.
• Select, contract, and manage CDMOs, CROs, and testing labs; oversee tech transfer, scale-up, and validation.
• Drive commercial readiness including PPQ, stability programs, and pre-approval inspections.
• Author and review CMC content for global filings (IND, NDA, MAA) and interact with health authorities.
• Anticipate technical and supply risks and implement mitigation plans.
• Establish governance connecting CMC with internal functions and external partners.
• Build and manage the CMC budget and external spend.

Skills

CMC leadership

Outsourced development

Regulatory liaison

Budget management

Cross-functional leadership

Education

MS or PhD in chemistry or related

Job description

Engage Scientific is seeking a Vice President, Head of CMC (Small Molecule) to lead all CMC activities in a fully outsourced model. You will direct drug substance, drug product, analytics, manufacturing, and supply chains, collaborating with regulators and finance to drive late-stage development and lifecycle management.

The role requires 15+ years in pharma/biotech with deep CMC experience, strong leadership, and a track record of successful external partnerships, tech transfer, and NDA/MAA