Senior Process Chemistry Scientist — Drug Substance Leader

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 165,000 - 185,000; Full time

Benefits offered by this job

Stock options

401(k) matching

Discretionary quarterly bonus

Flexible wellness benefit

PTO

Job summary

Praxis Precision Medicines, Inc. is seeking a Principal Scientist in Process Chemistry to lead drug substance activities across clinical and commercial programs.

You will shape both early and late-stage processes, advancing from lab to pilot plant while ensuring GMP compliance and regulatory readiness. You will collaborate with CMC, analytical, operations and QA teams, guiding external partners and shaping the data package for regulatory submissions.

Qualifications

• Advanced degree or 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.
• Experience with 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 with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus.
• Demonstrates intellectual curiosity, innovation and entrepreneurial spirit; thrives in an agile environment.
• Excellent interpersonal and communication skills, with ability to build relationships and promote diversity.

Responsibilities

• Leads the Process Chemistry R&D for one or more projects from early to late phase.
• Designs early and late-phase/commercial drug substance processes 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 CMC team to deliver clinical and commercial drug substance to Praxis programs.
• Identifies and leads external CRO/CMO partnerships to achieve deliverables.
• Analyzes external data to drive synthetic plans at CROs and CDMOs.
• Authoring or co-authoring regulatory submissions.
• Defines manufacturing strategy and GMP requirements.
• Assesses new trends in process development, quality and manufacturing for Praxis products.
• Manages quarterly budgeting of drug substance activities.
• Contributes to inventions and strengthens IP position.

Skills

Process Chemistry

CMC for small molecules

Regulatory submissions

Cross-functional leadership

cGMP knowledge

External collaboration (CRO/CMO)

Continuous processing / catalysis

Salt/crystalline form selection

Oligonucleotide chemistry (bonus)

Project leadership

Education

PhD in Chemistry

Job description

Praxis Precision Medicines, Inc. is seeking a Principal Scientist in Process Chemistry to lead drug substance activities across clinical and commercial programs.

You will shape both early and late-stage processes, advancing from lab to pilot plant while ensuring GMP compliance and regulatory readiness. You will collaborate with CMC, analytical, operations and QA teams, guiding external partners and shaping the data package for regulatory submissions.