Director/Senior Director, CMC, Drug Substance

Role Summary

Director/Senior Director, CMC, Drug Substance — manage and oversee the development and manufacturing of cGMP small molecule APIs for late-stage clinical trials through validation. Key member of a collaborative internal CMC team, primarily managing API development programs and manufacturing campaigns through CDMOs.

Responsibilities

• Manage and oversee the development and manufacturing of small molecule APIs in accordance with applicable quality and regulatory standards.
• Evaluate, recommend, and manage qualified CDMOs for the manufacture of API for clinical trials, as well as for commercial use.
• Participate in audits and inspections of API CDMOs in conjunction with Quality Assurance as the subject matter expert.
• Collaborate with the internal process chemistry team to manage API process technology transfer to CDMOs, including process validation and establishment/refinement of API specifications.
• Work with Supply Chain and CMC Drug Product colleagues to translate demand forecasts into API manufacturing plans.
• Author and/or review core CMC documents/modules and submissions/responses to FDA and other authorities, providing regulatory oversight and consistency.
• Plan and manage API-related budgets in line with strategic and operating plans and Finance policies.
• Direct, develop, coach and evaluate direct reports per HR policies.
• Develop short- and long-term objectives for the function aligned with company strategies.
• Ensure adherence to company policies and ethics codes; communicate policies to direct reports.
• Some international travel may be required.
• Other duties as assigned.

Qualifications

• PhD in Chemistry or related discipline with a minimum of 10 years of directly related experience in pharma/biotech; MSc with significant relevant experience may be considered.
• Track record managing development-stage and/or commercial-stage API manufacturing activities at CDMOs.
• Experience authoring/co-authoring key CMC sections in U.S. NDA and European MAA filings for small molecule APIs.
• Extensive knowledge of cGMP regulations, guidance documents, and best practices for APIs.
• Experience with CDMO selection, vendor management, contracting, issue resolution.
• Excellent written and oral communication skills; ability to communicate with scientific and non-scientific personnel; strong risk-based decision-making.
• Strong interpersonal and teamwork skills; able to work independently and within multidisciplinary teams.
• Scientifically data-driven with flexible strategic thinking and problem-solving abilities.

Education

• PhD in Chemistry or related discipline (or MSc with substantial relevant experience).

Location and Travel

Based in Boston, MA, USA (Needham office); hybrid role requiring a minimum of 2 days per week in the office. Some international travel may be required.