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Praxis

Focused patient recruitment.

Principal Scientist, Analytical Development, Oligo and Small Molecule

Research ScientistResearch ScientistFull TimeRemoteLeadTeam 11-50Since 2002H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

101 days ago

Salary

$165K - $185K / year

Seniority

Lead

Postgraduate Degree5 yrs expEnglish

Job Description

Principal Scientist, Analytical Development, Oligo and Small Molecule

Praxis

• 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.

Job Requirements

  • 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

  • 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.

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