Senior Director, CMC
1 month ago
Senior Director, Process Chemistry & Manufacturing
Watertown, MA
Our client is a mid-sized public company with approved products already on market. Located in the suburbs of Boston & Cambridge, they are seeking an experienced Process Chemistry leader to design, execute, and lead chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies and potential commercialization.
Reporting to the Head of CMC and supporting the entire company portfolio, the main function of this role is to lead a group of chemists and serve as a technical expert in the area of drug substance throughout the organization.
Responsibilities include but are not limited to:
- Lead the team in the design of fit-for-purpose synthetic processes and production of drug substance for GLP tox and clinical supplies.
- Manage project assignment and work distribution for process development group.
- Oversee the selection, tech transfer, process validation, and execution of drug substance development and manufacturing plans at external partners.
- Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA)
- Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
Formal descriptions can be supplied for interested candidates.
Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales. Must have demonstrated leadership in managing small teams, multiple projects, and budget. Experience with Quality by Design (QbD) and Design of Experiments (DoE) is welcome.
This is a primarily on-site role, leading a small team of PhD-level chemists. Must be commutable to the Greater Boston area or able to relocate with assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.
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