Lead Process Chemistry Scientist (Remote)

Praxis Precision Medicines, Inc.; United States; Remote; USD 165,000 - 185,000; Full time

Benefits offered by this job

Medical/dental/vision (premium paid)

Life insurance

AD&D

Disability benefits

Voluntary benefits

401(k) match

Stock incentives

ESPP

Discretionary bonus

Wellness benefit

PTO

Job summary

Praxis Precision Medicines, Inc. seeks a Principal Scientist in Process Chemistry to lead drug substance activities for multiple projects, supporting clinical and commercial supply.

You will design processes from lab to pilot plant and guide tech transfer within Agile teams to meet regulatory data package requirements. You will collaborate with formulations, analytics, operations, engineering and quality groups, manage CRO/CMO partnerships, and shape GMP strategies.

Qualifications

• Advanced degree or commensurate experience in Organic Chemistry, Pharmaceutical Sciences, Engineering or related discipline.
• Minimum of 5+ years of industry experience in CMC specifically for small molecule drug substance.
• Track record or working knowledge in 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 third-party CRO/CMO partners to develop and manufacture pharmaceutical products.
• Experience with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus.

Responsibilities

• Leads Process Chemistry R&D for projects from early to late phase.
• Designs early and late-phase/commercial drug substance processes and leads their demonstration from lab to pilot plant.
• Provides chemistry and technical leadership throughout the lifecycle.
• Collaborates with formulation, analytical, operations, engineering and quality to deliver clinical and commercial drug substance.
• Identifies, collaborates with and leads CRO/CDMO partners to achieve deliverables.
• Analyzes external data to guide synthetic experimental plans at CROs and CDMOs.
• Authoring or co-authoring of regulatory submissions.
• Defines manufacturing strategy including GMP requirements and issue resolution.
• Assesses new trends in process development, quality and manufacturing.
• Manages quarterly budgeting of drug substance activities.
• Contributes to inventions strengthening IP position.

Skills

Process Chemistry

Continuous Processing

Catalysis

Biocatalysis

High Throughput

Education

Advanced degree in Organic Chemistry / Pharmaceutical Sciences

Job description

Praxis Precision Medicines, Inc. seeks a Principal Scientist in Process Chemistry to lead drug substance activities for multiple projects, supporting clinical and commercial supply.

You will design processes from lab to pilot plant and guide tech transfer within Agile teams to meet regulatory data package requirements. You will collaborate with formulations, analytics, operations, engineering and quality groups, manage CRO/CMO partnerships, and shape GMP strategies.