Director, Process Chemistry: Lead Drug Substance Development

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 215,000 - 235,000; Full time

Job summary

Praxis Precision Medicines, Inc. in Boston is seeking a Director of Process Chemistry to lead drug substance activities across programs, driving clinical and commercial readiness.

You will design and mature processes from lab to pilot plant, collaborating with CMC, formulations, analytical, operations and quality to deliver regulatory-ready drug substance. This role requires a strong track record in small-molecule CMC, leadership in process development, and a hands-on, collaborative approach to

Qualifications

• Advanced degree or commensurate experience equivalent in Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum 12 years of industry experience in CMC specifically for small molecule drug substance.
• Experience with salt/crystalline form selection preferred.

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 process 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, integrated into the CMC team for clinical and commercial delivery.
• Identify, collaborate and lead external CRO, and CDMO organizations to achieve deliverables.
• Analyze external 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.
• Manage quarterly budgeting of drug substance relevant activities.
• Contributor to inventions that add value to Praxis and its patients while strengthening IP.

Skills

Process Development Leadership

Small Molecule CMC

Continuous Processing

Biocatalysis/Catalysis

High Throughput Experimentation

cGMP Knowledge

External Partner Management

Project Management

Regulatory Submissions

Education

Advanced degree in Chemistry or related field

Job description

Praxis Precision Medicines, Inc. in Boston is seeking a Director of Process Chemistry to lead drug substance activities across programs, driving clinical and commercial readiness.

You will design and mature processes from lab to pilot plant, collaborating with CMC, formulations, analytical, operations and quality to deliver regulatory-ready drug substance. This role requires a strong track record in small-molecule CMC, leadership in process development, and a hands-on, collaborative approach to