Director, Process Chemistry

Role Summary

Director of Process Chemistry – This position can be performed remotely, with travel as needed. You will lead drug substance activities for one or more Praxis projects in small molecule and ASO programs to drive clinical and commercial readiness. You will design products and processes that support clinical testing and mature those processes through development to commercial supply. Working closely with CMC and project teams under Agile management, you will identify requirements and constraints to define a work plan that delivers manufacturing readiness and a data package to support commercial regulatory submissions.

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 processes and leads their demonstration from lab to pilot plant.
• Provides chemistry and technical leadership throughout the lifecycle.
• Participates in or leads activities to identify final API forms for pharmaceutical development.
• Works closely with formulations, analytical, operations, engineering and quality, integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs.
• Identifies, collaborates with, and leads external CRO and CDMO organizations to achieve deliverables.
• Analyzes external experimental data to drive synthetic experimental plans at CROs and CDMOs.
• Authoring or co-authoring of regulatory submissions.
• Defines manufacturing strategy and execution, including GMP requirements and issue resolution.
• Assesses and applies new trends and concerns in process development, quality and manufacturing to Praxis’ products.
• Manages quarterly budgeting of drug substance relevant activities.
• Contributes to inventions that add value to Praxis and its patients while strengthening our intellectual property position.

Qualifications

• 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 manufacture 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.

Additional Requirements

• Physical and mental requirements include regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You’ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.