Principal Scientist, Analytical Development

Job not on LinkedIn

🕒 October 14

🇺🇸 United States – Remote

💵 $170k - $190k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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 the Analytical Lead for small molecule CMC programs • Lead analytical method development, qualification, validation, transfer, and GMP testing across internal teams and external CRO/CMO partners • Develop and implement phase-appropriate analytical control strategies, specifications, and stability programs • Provide technical leadership for analytical troubleshooting, data interpretation, impurity characterization, method lifecycle management, and analytical investigations • Review and approve analytical methods, validation and qualification reports, stability reports, specifications, certificates of analysis, and other CMC documentation • Direct and manage external CRO/CMO analytical partners • Support regulatory submissions, commercialization readiness, and product lifecycle management • Partner with Drug Substance, Drug Product, Quality, Regulatory, Manufacturing, and external teams to strengthen scalable analytical processes

🎯 Requirements

• Advanced degree in Analytical Chemistry or a related discipline; PhD preferred, Master’s with significant industry experience considered • 8+ years of relevant industry experience • Strong industry experience in analytical development for small molecule drug substances and drug products, including solid oral dosage forms • Deep knowledge of impurity characterization, assay and purity testing, stability assessment, and GMP analytical control strategies • Strong understanding of US and EU cGMP requirements and analytical best practices • Experience supporting CMC development across analytical development, regulatory submissions, method validation and transfer, and commercialization activities • Experience managing external CRO/CMO analytical networks • Strong working knowledge of quality systems, reference standards, stability programs, specifications, and compendial testing requirements • Flexibility and willingness to travel as needed

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) matching up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns