Director/Senior Director, CMC, Drug Substance

About the Role

We are seeking a Director/Senior Director, CMC, Drug Substance to join our team. The Director/Senior Director will help manage and oversee the development and manufacturing of cGMP small molecule active pharmaceutical ingredients (APIs) for late‑stage clinical trials through validation. The role is a key member of a highly collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns (i.e., registration, validation), and managing CDMO selection and technical transfer processes.

Position reports to the Executive Director, CMC, Drug Substance and is based in Boston, MA, USA. Remote locations may be considered for exceptional candidates. This is a hybrid position requiring a minimum of two onsite days per week.

Responsibilities

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recom...