Vice President, Head of CMC

Engage Scientific; Boston (MA); Sur place; USD 260 000 - 380 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CMC leadership

Outsourced development

Regulatory liaison

Budget management

Cross-functional leadership

Formation

MS or PhD in chemistry or related

Description du poste

(Only candidates residing in the US will be considered)

Vice President, Head of CMC (Small Molecule)

Engage Scientific is partnering with a clinical-stage biopharmaceutical company advancing a small molecule portfolio toward late-stage development and commercialization.

The Opportunity

This leader will be the single point of internal accountability for all CMC activities, including drug substance, drug product, analytical development, clinical manufacturing, and supply. The operating model is fully outsourced. The company relies on contract manufacturers, contract research organizations, and contract testing laboratories. This person will set direction for that network, hold it accountable, and make the key technical and strategic decisions. The role reports into executive leadership and partners closely with Regulatory, Quality, Clinical, and Finance.

What You Will Do

• Build and own a CMC strategy that carries programs from clinical development through registration, launch, and lifecycle management
• Select, contract, and manage CDMOs, CROs, and testing labs, setting priorities, reviewing deliverables, and overseeing tech transfer, scale-up, and validation
• Drive commercial readiness, including PPQ, process and method validation, stability programs, commercial supply qualification, and pre-approval inspection preparation
• Author and review CMC content for global filings (IND, CTA, IMPD, NDA, MAA) and represent CMC in interactions with health authorities and during inspections
• Anticipate technical and supply risks and put mitigation plans in place before they affect timelines
• Establish governance and working processes that connect CMC with internal functions and external partners
• Build and manage the CMC budget, including forecasting for new work and oversight of external spend

What You Bring

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

How You Lead

• You turn scientific and engineering judgment into clear decisions. You can explain complex CMC issues to technical and non-technical audiences, including executives and the board. You hold external partners to high standards without needing a large internal team. You are comfortable in a lean, fast-moving environment; you work with urgency and are as willing to dig into the details as to set long-range strategy. You lead with integrity and don't compromise on quality or compliance.