Senior Scientist, Analytical Science – Technology

🔥 19 minutes ago

🐎 Kentucky, New Hampshire, +12 more states – Remote

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🎸 Mississippi – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote 🧀 Wisconsin – Remote

💵 $140k - $155k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Healthcare • Manufacturing • Biotechnology

Aurion Biotech is a clinical-stage company developing first-in-class regenerative cell therapies to restore vision by treating corneal endothelial disease and other causes of blindness. The company focuses on manufacturing-scale cell therapy platforms, using human donor corneal endothelial cells combined with supportive compounds (e. g. , rho-kinase inhibitor) to repopulate the corneal endothelium, reduce reliance on donor tissue, and enable less-invasive alternatives to graft-based keratoplasty. Aurion conducts global clinical trials, holds FDA Breakthrough Therapy and RMAT designations for its lead product AURN001, and aims to expand access to advanced ophthalmic care worldwide.

📋 Description

• Lead all method transfers and validations at external CDMOs • Author and review protocols, review raw data, and author reports • Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development • Review outsourced GMP work • Serve as Lead SME for method validations, assay control establishment, and method bridging/USP equivalency testing • Build and maintain tools to monitor assay validity • Periodically assess assay validity and investigate as needed • Build collaborative relationships with external CMOs, contract labs, and internal Analytical Development, CMC, and Quality Assurance stakeholders • Independently investigate and resolve technical issues • Develop technical proposals and implement solutions • Escalate challenges to management • Monitor test methods, SOPs, and QC analytical data for compliance with cGMPs, pharmacopeial, and regulatory requirements • Provide technical support for deviations and laboratory investigations • Evaluate proposed analytical change requests • Maintain flexibility as is phase appropriate • Perform other duties as assigned

🎯 Requirements

• 5+ years of experience in Quality Control or another related function with a Master’s Degree, or a PhD with 2 years of relative QC experience • 8+ years of experience in Quality Control or another related function with a Bachelor’s Degree • Experience with method validations and USP method verification in late-stage clinical development • Excellent working knowledge of cGMP requirements, pharmacopeial and relevant EMA, FDA, and ICH guidelines as they relate to QC testing for cell therapy and method validations • Experience reviewing analytical test results and solving technical problems associated with a wide variety of cell-based QC assays • Hands-on experience with and deep understanding of Flow Cytometry • Experience charting data and identifying trends observed during studies • Working experience with statistical analysis software; JMP highly preferred • Ability to identify risks associated with method qualifications and validations, with a proven track record of resolving challenges • Demonstrated expertise in analytical method lifecycle management, including test method approval, method verification, method validation, and method transfer • Proven ability to interface with CDMOs • Ability to rapidly adapt to changing environments and circumstances while ensuring cGMP and regulatory requirements are met • Ability to collaborate cross-functionally at all organizational levels • Ability to manage assigned project deliverables • Strong written and verbal communication skills and ability to summarize scientific data clearly and persuasively • Quality mindset and ability to address compliance gaps • Advanced proficiency in MS Office products • Ability to work independently and with team members • Ability to travel up to 15%

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • EAP • FSA • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages