Principal Scientist, Process Chemistry

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

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 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.

Compensation & Benefits

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&DD, 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!

Annualized Base Salary: $165,000 USD - $185,000 USD

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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