Principal Engineer, MSAT

🔥 18 hours 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

💵 $157k - $174k / year

⏰ Full Time

🔴 Lead

🧑‍💻 Full-stack Engineer

🦅 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 technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment, or material changes • Develop and lead technical workstreams for late-stage and commercial process changes at GMP sites • Conduct technical risk assessments, change controls, impact assessments, comparability considerations, and GMP implementation • Lead late-stage and commercial technology transfer workstreams, including transfer planning, facility/process fit, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness • Own or support technology transfer packages, change controls, technical risk assessments, comparability plans/data packages/reports, process control strategy, execution protocols/reports, batch records, and regulatory source documents • Provide on-site PiP support, troubleshoot process issues, and drive technical investigations, deviations, change controls, and CAPAs to resolution • Establish and evaluate manufacturing data and process performance trends using statistical tools • Identify variability, shifts, and opportunities to improve process consistency, yield, robustness, and compliance • Manage deviation and change-control impact assessments, root-cause analysis, and timely closure of tech transfer investigations • Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation support continuous GMP manufacturing • Ensure effective business continuity plans • Serve as a technical and GMP subject matter expert within cross-functional technical execution • Partner with GMP manufacturing sites to transfer and sustain robust, compliant commercial manufacturing processes

🎯 Requirements

• B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required • 10+ years with a B.S.; 7+ years with an M.S.; or 5+ years with a Ph.D. of relevant industry experience • Significant experience in MSAT, Manufacturing, Process Development, or related functions supporting late-stage or commercial biologics or cell therapies • Demonstrated commercial-stage comparability, including comparability supporting manufacturing site transfers, process, equipment, or material changes, or other post-approval/lifecycle manufacturing changes • Demonstrated experience leading late-stage or commercial technology transfer workstreams and working directly with GMP manufacturing sites • Experience with engineering/GMP manufacturing, validation/PPQ, technical deviations, and manufacturing investigations • Experience authoring risk assessments, technical documentation and source documents supporting CMC regulatory submissions • Experience supporting regulatory responses or inspections preferred • Experience leading cross-functional technical subteams and influencing GMP manufacturing partners through complex technical issues and implementation • Cell therapy experience strongly preferred • Experience across multiple commercial manufacturing sites or products a plus • Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies • Strong knowledge of technology transfer, commercial comparability, GMP manufacturing, validation/PPQ, process control strategy, deviation/change control, and commercial lifecycle management • Ability to independently lead complex technical workstreams, implement commercial lifecycle changes, and develop technical approaches with limited direction • Strong technical writing and document review skills • Strong analytical, troubleshooting, and data-analysis skills • Ability to lead cross-functional technical subteams, influence external manufacturing partners, and mentor junior technical staff without direct management responsibility • Background in cell therapy, viral vector, or other complex biologic modalities with hands-on GMP manufacturing experience preferred • Travel required up to 35%

🏖️ Benefits

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