Principal Scientist, Process Chemistry

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
We’re seeking a Principal Scientist in Process Chemistry to lead drug substance activities for one or more projects within Praxis’ portfolio to support clinical and commercial supply. Apply your knowledge to design products & processes to support clinical phase testing and then mature them through development to commercial supply. You are a key leader in the development of drug substance processes for our small molecule products. You’ll also work closely within the CMC and project teams under Agile management to identify requirements and constraints of our product in order to define a work plan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.
Primary Responsibilities
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 which add value to Praxis and its patients while strengthening our intellectual property position.
Qualifications and Key Success Factors
Advanced degree or commensurate experience equivalent in Organic Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
A scientific track record or working knowledge in continuous processing, catalysis, biocatalysis and/or high throughput experimentation desirable.
Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.