Director/Senior Director, CMC Drug Substance Development

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

Join us in transforming the lives of patientsAre you passionate about making a significant impact in improving patients' lives? At Enanta, we are committed to discovering and developing novel small molecule drugs for indications in virology and immunology. Our collaborative, fast-paced environment empowers every team member to meaningfully contribute to our goal of advancing healthcare and improving patient outcomes.

What You'll Do

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. You will:

• 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.

What You Bring

Educational Background: PhD degree in chemistry, chemical engineering, or a related scientific field with 10+ years of experience in drug substance development and manufacturing.

Leadership Experience: Demonstrated leadership managing people, multiple projects, and budgets in a fast-paced pharmaceutical or biotechnology environment.

Scale-Up Expertise: Proven track record developing and scaling chemical processes from laboratory scale to kilolab, pilot plant, and commercial plant.

Technical Expertise: Extensive knowledge of, and hands-on experience with, laboratory and plant equipment and processes commonly used for synthetic chemistry, plus knowledge of radiolabeled synthesis.

GMP, Safety, and Partner Management: 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.

Regulatory and Communication Skills: 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.

What Sets You Apart

Quality by Design: Experience applying statistical design and analysis of experiments; experience with Quality by Design (QbD) is preferred.

Industry Leadership: Demonstrated success leading drug substance development and manufacturing in the pharmaceutical or biotech industry.

CDMO Strategy and Oversight: Experience setting strategy and overseeing global CDMOs across process research, non-GMP production, GMP manufacturing, tech transfer, and validation.

Cross-Functional Influence: A collaborative leadership style that helps align internal stakeholders and external partners around high-quality execution and corporate goals.

Our Core Values

At Enanta, we foster a culture driven by the following 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.

Why Join Us?

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.

Enanta is committed to providing compensation transparency. 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.

How To Apply

Please complete the application below and include the following attachments:

• Cover Letter
• CV / Resume
• Research Summary (if applicable)

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. Please visit www.enanta.com for more information.

Enanta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.