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.
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)
