Note: The job is a remote job and is open to candidates in USA. Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Principal Scientist, Analytical Development will lead analytical strategies for oligonucleotide and small molecule programs, ensuring robust and compliant control strategies while collaborating with various teams to advance the company's pipeline.
Responsibilities
- Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development activities and support for small molecule programs
- Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external partners
- Drive technical troubleshooting, data interpretation, method lifecycle management, and review of analytical documentation including validation reports, stability reports, specifications, and CoAs
- Design and implement phase-appropriate analytical control strategies, specifications, and stability programs for oligonucleotide and small molecule drug substances and drug products
- Direct and manage CRO/CMO analytical partners to ensure high-quality execution, strong communication, and continuous operational improvement
- Collaborate cross-functionally to strengthen CMC operations, improve processes, and establish scalable technical and business practices across the analytical function
- Contribute strategic and technical expertise to support regulatory filings, commercialization readiness, and ongoing product lifecycle management
Skills
- Advanced degree (PhD preferred; Master's with significant industry experience considered) in Analytical Chemistry or related discipline with 5–7+ years of industry experience
- Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products required
- Deep knowledge of analytical techniques relevant to oligonucleotides, including impurity characterization, stability assessment, and GMP control strategies
- Strong understanding of US and EU cGMP requirements and analytical best practices for drug substance and drug product development
- Experience supporting CMC development across multiple stages of development, including regulatory submissions, validation, and commercialization activities
- Experience managing external CRO/CMO analytical networks and building productive technical partnerships
- Strong working knowledge of quality systems, reference standards, stability programs, and compendial testing requirements
- Experience supporting small molecule drug substances and solid oral dosage forms strongly preferred
Benefits
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- Dollar-for-dollar match up to 6% on eligible 401(k) contributions
- Long-term stock incentives and ESPP
- Discretionary quarterly bonus
- Extremely flexible wellness benefit
- Generous PTO
- Paid holidays and company-wide shutdowns
Company Overview
Company H1B Sponsorship