Senior Director, Chemical Process Development & Manufacturing
Enanta Pharmaceuticals
- Watertown, MA
- Permanent
- Full-time
The Senior Director, Chemical Process Development and Manufacturing will design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization. This position will lead a group of chemists and serve as a technical expert in the area of drug substance throughout the organization and will coordinate/author/review drug substance relevant sections of regulatory documents. In addition, the successful candidate will oversee the selection, tech transfer and execution of drug substance development and manufacturing plans at external partners. The candidate must have extensive leadership and first-hand experience in equipment and processes commonly used for chemical synthesis. This position reports to the Vice President, CMC.Primary Responsibilities:
- Serves as the functional leader in drug substance process development and manufacturing in alignment with our clinical trial plans and corporate goals.
- Design fit-for-purpose synthetic process and produce drug substance for GLP tox and clinical supplies.
- Manages project assignment and work distribution for chemical process development group.
- Screen and select external partners for process research, non-GMP and GMP production of drug substances.
- Conducts physicochemical characterization of different drug substances, salt and form screen.
- Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
- Leads process development and drug substance manufacturing activities at external laboratories and manufacturing facilities.
- Authors and reviews drug substance related sections for regulatory filings, development reports and other development related documents.
- Actively communicates, collaborates with and contributes to other cross-functional areas to advance corporate goals.
- Oversees tech transfer and process validation of drug substance manufacturing processes.
- Set strategy on managing global CDMOs including authoring and reviewing of Batch Records/Master Production Records and specifications.
- Some travel (10-20%) required for this position.
- PhD degree in chemistry, chemical engineering or related scientific field with 12+ years’ experience in drug substance development and manufacturing.
- The successful candidate has demonstrated leadership in managing people, multiple projects, and budget.
- A proven track record in developing and scaling up chemical process from laboratory scale to kilolab, pilot plant and commercial plant.
- Extensive knowledge and hands on experience with laboratory and plant equipment and processes commonly used for synthetic chemistry; Knowledge of radiolabeled synthesis.
- Strong knowledge of GMP compliance, process safety and plant operations.
- Experience in applying statistical design and analysis of experiments and experience with Quality by Design (QbD) is preferred.
- Experience in 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 on writing and reviewing regulatory documents (IND, IMPD, NDA and MAA).
- Excellent verbal and written communication skills, ability to effectively work across levels, functional areas and with external partners.
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
This is a full time position