Director/Senior Director, CMC Drug Substance Development

About the role

As a Director/Senior Director, CMC Drug Substance Development, you will be an integral part of our CMC team, where your work will directly impact our innovative R&D projects. Reporting to the Vice President, CMC, you will design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies, and potential commercialization. You will serve as a technical expert for drug substance development across the organization, lead a group of chemists, and coordinate, author, and review drug substance sections of regulatory documents.

Responsibilities

• Lead Drug Substance Strategy: Serve as the functional leader for drug substance process development and manufacturing, aligning development and manufacturing strategy with clinical trial plans and corporate goals.
• Design and Execute Development Plans: Design fit-for-purpose synthetic processes and produce drug substance for GLP toxicology studies, clinical supplies, and potential commercialization.
• Lead and Manage Team Execution: Lead a group of chemists, manage project assignments and work distribution, and provide technical expertise in drug substance development across the organization.
• Select and Oversee External Partners: Screen, select, and manage global external partners for process research, non-GMP production, GMP production, tech transfer, validation, and drug substance manufacturing activities.
• Collaborate Across Functions: Work closely with Project Management, CMC, discovery, non-clinical development, formulation development, analytical development, Quality Assurance, and CMC Regulatory Affairs.
• Author and Review CMC Documentation: Coordinate, author, and review drug substance sections of regulatory filings, development reports, batch records, master production records, specifications, and related documents; travel approximately 10-20% as needed.

Requirements

• PhD degree in chemistry, chemical engineering, or a related scientific field with 10+ years of experience in drug substance development and manufacturing.
• Demonstrated leadership managing people, multiple projects, and budgets in a fast-paced pharmaceutical or biotechnology environment.
• Proven track record developing and scaling chemical processes from laboratory scale to kilolab, pilot plant, and commercial plant.
• Extensive knowledge of, and hands-on experience with, laboratory and plant equipment and processes commonly used for synthetic chemistry, plus knowledge of radiolabeled synthesis.
• Strong knowledge of GMP compliance, process safety, plant operations, and experience screening, selecting, and managing global external partners for chemical process research, development, and manufacturing.
• Strong knowledge of FDA and global CMC regulatory guidance, first-hand experience writing and reviewing IND, IMPD, NDA, and MAA documents, and excellent verbal and written communication skills.

Skills

• Experience applying statistical design and analysis of experiments; experience with Quality by Design (QbD) is preferred.
• Demonstrated success leading drug substance development and manufacturing in the pharmaceutical or biotech industry.
• Experience setting strategy and overseeing global CDMOs across process research, non-GMP production, GMP manufacturing, tech transfer, and validation.
• A collaborative leadership style that helps align internal stakeholders and external partners around high-quality execution and corporate goals.

Benefits

At Enanta Pharmaceuticals, you will be part of a team working on projects and programs that truly matter. We offer a supportive, inclusive environment where innovation is not just encouraged but celebrated. You’ll have the opportunity to grow, collaborate, and make a tangible impact.

Pay

The expected base salary range for this position is $173,000 to $285,333, based on experience, qualifications, and market conditions. Offers will be determined by several factors, including individual experience and expertise, ensuring both equity and competitiveness.

About Enanta

Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT, STAT6 and MRGPRX2 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations.

Core Values

• Curiosity: You demonstrate an unrelenting desire to explore, question, and innovate.
• Respectful: You engage with colleagues and partners with professionalism and care.
• Empathy: You are compassionate, both in teamwork and when thinking about patient impact.
• Agility: You thrive in fast-paced environments and adapt quickly to changing circumstances.
• Team-Oriented: You embrace collaboration, understanding that success comes from collective efforts.
• Entrepreneurial Spirit: You are proactive, continuously seeking opportunities to improve and grow.