Principal Scientist, Analytical Development, Oligo and Small Molecule
About The Position
The Principal Scientist, Analytical Development will advance Praxis’ clinical and commercial pipeline by translating analytical strategies from development into manufacturing across a virtual network of CMOs and external partners. The role primarily focuses on oligonucleotide-based therapeutics and also supports small molecule programs. It requires deep expertise in analytical method development, qualification, validation, troubleshooting, and GMP testing for oligonucleotide drug substances and drug products, as well as the ability to apply phase-appropriate analytical strategies across multiple modalities. This is a highly cross-functional, hands-on leadership role partnering with Drug Substance, Drug Product, Quality, Regulatory, and Manufacturing teams to establish robust, scalable, and compliant analytical control strategies. The successful candidate will help shape an agile analytical development function supporting CNS therapies from early development through commercialization. The position may be performed remotely and requires flexibility and willingness to travel as needed.
Requirements
- Advanced degree in Analytical Chemistry or a related discipline; a PhD is preferred, while a Master’s degree with significant industry experience is considered.
- 5–7+ years of industry experience.
- Strong industry experience in analytical development for oligonucleotide drug substances and/or drug products.
- 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, 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.
Nice To Haves
- Experience supporting small molecule drug substances and solid oral dosage forms.
Responsibilities
- Serve as Analytical Lead across CMC programs, with primary responsibility for oligonucleotide analytical development and support for small molecule programs.
- Lead analytical method development, qualification, validation, transfer, and GMP testing across internal teams and external partners.
- Drive technical troubleshooting, data interpretation, and method lifecycle management; review 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.
- Provide strategic and technical expertise for regulatory filings, commercialization readiness, and ongoing product lifecycle management.
Benefits
- Medical, dental, and vision plans with 99% of the premium paid.
- Company-paid life insurance, AD&D, and disability benefits, plus voluntary plans.
- Dollar-for-dollar 401(k) match up to 6% on eligible contributions.
- Long-term stock incentives and an employee stock purchase plan (ESPP).
- Discretionary quarterly bonus.
- Flexible wellness benefit.
- Generous paid time off, paid holidays, and company-wide shutdowns.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
