Director, Process Chemistry

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

As Director of Process Chemistry, you will take the lead on drug substance activities for one or more projects within Praxis’ portfolio of small molecule programs to drive forward both clinical and commercial readiness.  You’ll design products & processes that support clinical phase testing and then mature those processes through development to Commercial supply.  Working intimately within the CMC and project teams under Agile management you’ll identify requirements and constraints of our product to define a workplan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions. 

This role is ideal for someone who thrives in a fast-moving, collaborative environment, where science meets ownership. You’ll help define product requirements, anticipate challenges, and co-create practical, creative solutions that accelerate progress for patients in urgent need. 

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 that 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 Chemistry, Pharmaceutical Sciences, Engineering or related discipline. 
• Minimum of 12 years of industry experience in CMC specifically for small molecule drug substance. 
• A scientific track record or working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation desirable. 
• Strong knowledge of US and EU cGMP requirements and best practices relating to drug substances and drug products.  
• Strong knowledge of CMC development across all phases of drug development from initial regulatory filings through registration, validation and launch. 
• Experience in working with third-party CRO / CMO partners and associated service providers to develop and manufacturing pharmaceutical products. 
• Experience with salt/crystalline form selection preferred. 
• Experience with oligonucleotide chemistry is a plus 
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment. 
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms. 
• Highly organized and detail-oriented with a passion to deliver quality results.