Principal Scientist, Analytical Development

The posting, as Praxis Precision Medicines, Inc. wrote it

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 techni

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rapies 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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