Director, Process Chemistry

The role

You will lead drug substance activities for small molecule programs to drive clinical and commercial readiness. You will design products and processes, manage external CRO and CDMO partners, and author regulatory submissions.

What you will do

• Leads the Process Chemistry Research and Development for one or more projects from early to late phase
• Designs early phase and late-phase/commercial drug substance process and leads 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
• Works with formulations, analytical, operations, engineering and quality as part of the CMC team
• Identify, collaborate and lead external CRO, and CDMO organization(s)
• 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
• Manage quarterly budgeting of drug substance relevant activities

Required 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
• 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

Nice to have

• Working knowledge in continuous processing, biocatalysis, catalysis, and/or high throughput experimentation
• Experience with salt/crystalline form selection
• Experience with oligonucleotide chemistry

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans
• 401(k) match up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.