Praxis Precision Medicines, Inc. · 2 weeks ago
Principal Scientist, Process Chemistry
United States
Full-time
Remote
Senior Level, Lead/Staff
$165K/yr - $185K/yr
5+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Principal Scientist in Process Chemistry will lead drug substance activities for projects, designing processes and collaborating with various teams to ensure successful manufacturing and regulatory submissions.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
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
Qualification
Required
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
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
Preferred
Experience with salt/crystalline form selection preferred
Experience with oligonucleotide chemistry is a plus
Benefits
99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage.
401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
2026-01-11
2026-01-07
Company data provided by crunchbase