Principal Scientist, Analytical Development, Oligo and Small Molecule

Praxis

Principal Scientist focused on analytical development for oligonucleotide-based therapeutics. Collaborating with CMC teams to ensure high-quality analytical strategies and support innovative CNS therapies.

Posted 5/20/2026full-timeRemote • 🇺🇸 United StatesLead💰 $165,000 - $185,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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 preferred.
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.

Benefits

Comp & perks

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.
401(k) contributions matched dollar-for-dollar up to 6%.
Long-term stock incentives and ESPP.
Discretionary quarterly bonus.
Flexible wellness benefit.
Generous PTO and paid holidays.
Company-wide shutdowns.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

analytical method developmentqualificationvalidationGMP testingdata interpretationmethod lifecycle managementimpurity characterizationstability assessmentanalytical control strategiescompendial testing

Soft Skills

leadershipcommunicationcollaborationstrategic expertiseoperational improvement

Certifications

PhD in Analytical ChemistryMaster’s in related discipline