Director, Drug Substance Development & Manufacturing

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

Job summary

Enanta Pharmaceuticals seeks a Director/Senior Director of CMC Drug Substance Development in Watertown, MA to lead drug substance process development and manufacturing strategy for GLP toxicology, clinical supplies, and potential commercialization. You will supervise a chemist team, coordinate regulatory submissions, and align development with clinical and corporate goals.

PhD in chemistry or related field with 10+ years of experience required; strong GMP, safety, regulatory writing, and

Qualifications

• PhD degree in chemistry, chemical engineering, or a related scientific field with 10+ years of experience in drug substance development and manufacturing.
• Strong knowledge of FDA and global CMC regulatory guidance and experience writing regulatory documents (IND/IMPD/NDA/MAA).
• Experience leading teams of chemists, project management, and budget oversight in pharma/biotech environments.

Responsibilities

• Lead Drug Substance Strategy: functional leader for drug substance process development and manufacturing, aligning with clinical trial plans and corporate goals.
• Design fit-for-purpose synthetic processes and produce drug substance for GLP toxicology studies, clinical supplies, and potential commercialization.
• Lead and manage a team of chemists, assign projects, and provide expertise across the organization.
• Select and oversee global external partners for research, non-GMP/ GMP production, tech transfer, validation, and manufacturing.
• Collaborate with Project Management, CMC, discovery, non-clinical development, formulation, analytical development, QA, and CMC Regulatory Affairs.
• Author and review drug substance sections of regulatory filings, development reports, and batch records; travel approx. 10-20% as needed.

Skills

Leadership

Regulatory knowledge

CMC documentation

Team management

Communication

GMP compliance

Education

PhD in chemistry or related field

Job description

Enanta Pharmaceuticals seeks a Director/Senior Director of CMC Drug Substance Development in Watertown, MA to lead drug substance process development and manufacturing strategy for GLP toxicology, clinical supplies, and potential commercialization. You will supervise a chemist team, coordinate regulatory submissions, and align development with clinical and corporate goals.

PhD in chemistry or related field with 10+ years of experience required; strong GMP, safety, regulatory writing, and