Principal Scientist, Process Chemistry

The role

The Principal Scientist leads drug substance activities for projects within the portfolio to support clinical and commercial supply. This role involves designing products and processes from early phase through commercial supply and providing technical leadership.

What you will do

• Leads Process Chemistry Research and Development for one or more projects
• Designs early phase and late-phase/commercial drug substance processes
• Leads process demonstration from lab to pilot plant
• Provides chemistry and technical leadership throughout the lifecycle
• Participates or leads activities to identify final API forms
• Works with formulations, analytical, operations, engineering and quality teams
• Identifies, collaborates with and leads external CRO and CDMO organizations
• Analyzes external experimental data to drive synthetic experimental plans
• Authors or co-authors regulatory submissions
• Defines manufacturing strategy and execution including GMP requirements

Required qualifications

• 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
• 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
• Experience in working with third-party CRO / CMO partners and associated service providers
• Excellent interpersonal and communication skills
• Highly organized and detail-oriented

Nice to have

• Scientific track record or working knowledge in continuous processing, catalysis, biocatalysis 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 to personalize coverage
• 401(k) match dollar-for-dollar up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Extremely 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.