Principal Scientist, Analytical Development, Oligo and Small Molecule

Job not on LinkedIn

🕒 May 20

🇺🇸 United States – Remote

💵 $165k - $185k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

Biotechnology • Healthcare Insurance • Science

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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.