Director, Process Chemistry
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Job Description
Director of Process Chemistry at Praxis Precision Medicines, leading drug substance activities for clinical and commercial readiness. Requires strong CMC experience and technical leadership.
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.
Requirements:
- 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.
Benefits:
- 99% of the premium paid for medical, dental, and vision plans.
- Company-paid life insurance, AD&D, and disability benefits.
- Voluntary plans to personalize coverage.
- 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous PTO, paid holidays, and company-wide shutdowns.
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