Senior Director, CMC Drug Substance Development

Enanta Pharmaceuticals, Inc.; Massachusetts; On-site; USD 173,000 - 285,000; Full time

Benefits offered by this job

Compensation transparency

Job summary

Enanta Pharmaceuticals, Inc. in Watertown, MA is seeking a Director/Senior Director, CMC Drug Substance Development to lead chemistry process development and manufacturing strategy for GLP toxicology, clinical supplies, and potential commercialization.

You will design fit-for-purpose synthetic processes, lead a team of chemists, and coordinate with CMC, QA, analytics and regulatory to author and review drug substance sections of filings and reports.

Qualifications

• PhD with 10+ years in drug substance development and manufacturing.
• Experience leading teams, projects, and budgets in pharma/biotech.
• Proven scale-up of processes from lab to commercial plant.
• Strong knowledge of GMP, safety, and CDMO management.
• Experience writing and reviewing regulatory filings (IND/IMPD/NDA/MAA).

Responsibilities

• Lead drug substance strategy and align with clinical plans.
• Design and execute development plans for drug substances.
• Manage chemist teams and project assignments.
• Coordinate external partners for process R&D and manufacturing.
• Collaborate with cross-functional functions including QA and Regulatory.
• Author/review CMC sections of filings and reports.

Skills

Leadership

Scale-Up expertise

GMP compliance

Regulatory writing (IND/IMPD/NDA/MAA)

CDMO strategy & oversight

Cross-functional collaboration

Project management

Radiolabeled synthesis

Biotech/pharma industry experience

Team management

Education

PhD in chemistry or chemical engineering

Job description

Enanta Pharmaceuticals, Inc. in Watertown, MA is seeking a Director/Senior Director, CMC Drug Substance Development to lead chemistry process development and manufacturing strategy for GLP toxicology, clinical supplies, and potential commercialization.

You will design fit-for-purpose synthetic processes, lead a team of chemists, and coordinate with CMC, QA, analytics and regulatory to author and review drug substance sections of filings and reports.