Remote Director, Process Chemistry & Drug Substance

Praxis Precision Medicines, Inc.; Boston (MA); On-site; USD 210,000 - 230,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking a Director of Process Chemistry to lead drug substance activities across multiple projects, advancing processes from early development to commercial readiness.

You will collaborate closely with CMC and project teams to define requirements, plan workstreams, and ensure robust data packages for regulatory submissions. The role demands a strong track record in small molecule CMC, leadership in cross-functional teams, and expertise in process development

Qualifications

• Minimum of 12 years of industry experience in CMC for small molecule drug substances.
• Strong knowledge of US and EU cGMP requirements and best practices.
• Experience managing CRO/CMO partnerships.
• Experience with salt/crystalline form selection and process development.
• Ability to lead cross-functional teams in Agile environments.

Responsibilities

• Leads Process Chemistry R&D for one or more projects from early to late phase.
• Designs both early phase and late-phase/commercial drug substance processes 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 with CMC delivery for Praxis programs.
• Identify, collaborate and lead external CRO, and CDMO organizations to deliver.
• Authoring or co-authoring of regulatory submissions.
• Define manufacturing strategy and GMP requirements.
• Assessment and application of new trends in process development, quality and manufacturing.
• Manage quarterly budgeting of drug substance relevant activities.

Skills

Process Chemistry

Leadership

Regulatory Compliance

Education

Advanced degree in Chemistry / Pharmaceutical Sciences / Engineering

Job description

Praxis Precision Medicines, Inc. is seeking a Director of Process Chemistry to lead drug substance activities across multiple projects, advancing processes from early development to commercial readiness.

You will collaborate closely with CMC and project teams to define requirements, plan workstreams, and ensure robust data packages for regulatory submissions. The role demands a strong track record in small molecule CMC, leadership in cross-functional teams, and expertise in process development