• Leads the Process Chemistry Research and Development for one or more projects from early to late phase within Praxis. • Designs both early phase and late-phase/commercial drug substance process and then leads their demonstration from lab to pilot plant. • Provides chemistry and technical leadership throughout the lifecycle. • Participates/leads activities to identify final API forms for pharmaceutical development. • Working closely with formulations, analytical, operations, engineering and quality, expectation to be integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs. • Identify, collaborate and lead external CRO, and CDMO organization(s) to achieve deliverables. • Analyze external experimental data to drive synthetic experimental plans at CROs and CDMO. • Authoring or co-authoring of regulatory submissions. • Define manufacturing strategy and execution, including GMP requirements and issue resolution. • Assessment and application of new trends and concerns in process development, quality and manufacturing to Praxis’ products. • Manage quarterly budgeting of drug substance relevant activities. • Contributor to inventions that add value to Praxis and its patients while strengthening our intellectual property position.