Principal Scientist, Analytical Development, Oligo and Small Molecule

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed. Position Summary  The Principal Scientist, Analytical Development will play a critical role in advancing Praxis’ clinical and commercial pipeline by translating analytical strategies from development into manufacturing across our virtual network of CMOs and external partners. This role is particularly focused on advancing oligonucleotide-based therapeutics, while also supporting small molecule programs across the portfolio. The individual will bring deep expertise in analytical method development, qualification, validation, troubleshooting, and GMP testing for oligonucleotide drug substances and drug products, with the ability to apply phase-appropriate analytical strategies across multiple modalities. This is a highly cross-functional, hands-on leadership role requiring close partnership with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to ensure robust, scalable, and compliant analytical control strategies. The successful candidate will help shape an agile, forward-looking analytical development function capable of supporting innovative CNS therapies from early development through commercialization.  Primary 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    Qualifications and Key Success Factors   Qualifications  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  Experience supporting small molecule drug substances and solid oral dosage forms strongly prefe...