Principal Scientist, Analytical Development

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The Opportunity
The Principal Scientist, Analytical Development, will play a critical role in advancing Praxis’ clinical pipeline by leading analytical development strategies for small molecule drug substances and drug products across our virtual network of CMOs and external partners.
This is a highly cross-functional, hands-on leadership role responsible for developing, qualifying, validating, transferring, and supporting GMP analytical methods and control strategies throughout the product lifecycle. The individual will provide deep technical expertise in analytical chemistry and small molecule development, with a strong understanding of phase-appropriate analytical strategies from early development through drug approval.
The successful candidate will partner closely with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to establish robust, scalable, and compliant analytical control strategies. This individual will help build an agile, forward-looking analytical development function capable of supporting innovative CNS therapies with scientific rigor, urgency, and a focus on patient impact.
Primary Responsibilities
Serve as the Analytical Lead for small molecule CMC programs, providing technical leadership across drug substance and drug product analytical development activities.
Lead analytical method development, qualification, validation, transfer, and GMP testing activities across internal teams and external CRO/CMO partners.
Develop and implement phase-appropriate analytical control strategies, specifications, and stability programs for small molecule drug substances and drug products.
Provide hands-on technical leadership for analytical troubleshooting, data interpretation, impurity characterization, method lifecycle management, and analytical investigations.
Review and approve analytical documentation, including methods, validation and qualification reports, stability reports, specifications, certificates of analysis, and other CMC documentation.
Direct and manage external CRO/CMO analytical partners to ensure high-quality execution, effective communication, timely delivery, and continuous technical and operational improvement.
Provide strategic and technical expertise to support regulatory submissions, commercialization readiness, and ongoing product lifecycle management while partnering cross-functionally to strengthen scalable analytical processes and practices.
Qualifications and Key Success Factors
Advanced degree (PhD preferred; Master’s with significant industry experience considered) in Analytical Chemistry or a related discipline with 8+ years of relevant industry experience.
Strong industry experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms.
Deep knowledge of analytical techniques and strategies relevant to small molecules, including impurity characterization, assay and purity testing, stability assessment, and GMP analytical 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, including analytical development, regulatory submissions, method validation and transfer, 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, specifications, and compendial testing requirements.