Principal Scientist, Process Chemistry

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

Location:

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

We're seeking a Principal Scientist in Process Chemistry to lead drug substance activities for one or more projects within Praxis' portfolio to support clinical and commercial supply. Apply your knowledge to design products & processes to support clinical phase testing and then mature them through development to commercial supply. You are a key leader in the development of drug substance processes for our small molecule products. You'll also work closely within the CMC and project teams under Agile management to identify requirements and constraints of our product in order to define a work plan that will lead to the successful manufacturing and creation of a data package to support commercial regulatory submissions.

Primary 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, expectation to be integrated into the overall CMC team responsible for delivery of clinical and commercial drug substance to Praxis programs.
• Identify, collaborate and lead external CRO, and CDMO organization(s) to achieve deliverables.
• Analyze external experimental 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 and issue resolution.
• Assessment and application of new trends and concerns in process development, quality and manufacturing to Praxis' products.
• Manage quarterly budgeting of drug substance relevant activities.
• Contributor to inventions which add value to Praxis and its patients while strengthening our intellectual property position.

Qualifications and Key Success Factors

• 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.
• A scientific 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 in working with third-party CRO / CMO partners and associated service providers to develop and manufacturing pharmaceutical products.
• Experience with salt/crystalline form selection preferred.
• Experience with oligonucleotide chemistry is a plus.
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• Excellent interpersonal and communication skills, with the ability to develop important relationships that include trust and encourage diversity in all its forms.
• Highly organized and detail-oriented with a passion to deliver quality results.
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

The physical and mental requirements of our roles include but is not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long‑term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company‑wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together!

$165,000 - $185,000 USD