Director, CMC Drug Substance Development (Onsite)

Enanta-Pharmaceuticals-; Watertown (MA); On-site; USD 173,000 - 285,000; Full time

Job summary

Enanta Pharmaceuticals in Watertown, MA is seeking a Director/Senior Director for CMC Drug Substance Development. You will lead strategy, design scalable processes, and manage a chemist team, coordinating regulatory submissions and external partnerships.

The role requires a PhD with 10+ years in drug substance development, strong GMP experience, and cross-functional leadership to drive programs from discovery through potential commercialization. Onsite in Watertown, with some travel.

Qualifications

• PhD in chemistry, chemical engineering, or a related scientific field with 10+ years of experience in drug substance development and manufacturing.
• Experience leading teams and budgets in pharma/biotech environments.
• Proven ability to scale chemical processes from lab to industrial scale.

Responsibilities

• Lead drug substance strategy and manufacturing alignment with clinical trial plans and corporate goals.
• Design fit-for-purpose synthetic processes for GLP toxicology, clinical supplies, and potential commercialization.
• Coordinate, author, and review drug substance sections of regulatory filings and development reports.

Skills

Leadership

Scale-Up

GMP Knowledge

Regulatory Knowledge

Cross-Functional Leadership

Project Management

Communication

Education

PhD in chemistry or related field

Tools

Radiolabeled synthesis

Job description

Enanta Pharmaceuticals in Watertown, MA is seeking a Director/Senior Director for CMC Drug Substance Development. You will lead strategy, design scalable processes, and manage a chemist team, coordinating regulatory submissions and external partnerships.

The role requires a PhD with 10+ years in drug substance development, strong GMP experience, and cross-functional leadership to drive programs from discovery through potential commercialization. Onsite in Watertown, with some travel.