Principal Scientist, Process Chemistry

The posting, as Praxis Precision Medicines, Inc. wrote it

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.
• 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 p

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rapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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