Director, Process Chemistry

About this role

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.

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