Senior Principal Engineer, MSAT

🔥 0 minutes ago

🐎 Kentucky, New Hampshire, +10 more states – Remote

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

💵 $180k - $202k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

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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 one or more tech transfers to manufacturing sites supporting late-stage clinical and commercial programs • Oversee CMC strategy implementation and manage CDMOs during tech transfer • Lead new site/suite readiness, risk assessments, tech transfer strategy, planning, risk mitigation, feasibility, engineering runs, comparability, and PPQ runs • Provide strategic input on and author CMC regulatory submission sections • Provide immediate response support as required • Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation support continuous GMP manufacturing • Ensure effective business continuity plans • Support GMP manufacturing execution, including on-site presence during initial campaigns, PiP, troubleshooting, and driving investigations to closure • Own or support process control strategies, tech transfer plans, batch records, risk assessments, comparability assessments, and change controls • Coordinate cross-functional execution with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain • Deliver tech transfers to GMP commercial readiness on accelerated timelines • Establish manufacturing data capture and ongoing trending • Perform data and statistical analysis with JMP as required • Drive deviation and change-control impact assessments, root-cause analysis, and closure of GMP investigations • Monitor Drug Substance and Drug Product performance metrics and recommend improvements in process consistency, yield, or compliance • Perform other duties as assigned

🎯 Requirements

• B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required • 12+ years of experience with a B.S., 10+ years with an M.S., or 6+ years with a Ph.D. • 5+ years of experience in MS&T, Manufacturing, or Process Development for biologics/cell therapies • Experience leading cross-functional teams, managing CDMOs, delegating responsibility, and solving complex problems • Experience with late-stage and commercial cell therapy required • Proven experience leading late-stage/commercial tech transfers, including CDMOs, process changes, technical deviations, comparability studies, and PPQ for cell therapies • Experience authoring and defending CMC sections of regulatory submissions and regulatory inspections • Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies • Background in cell therapy, viral vector, or another complex biologic modality • Demonstrated experience managing new site tech transfers in a fast-paced environment • Strong analytical and problem-solving skills with a data-driven mindset • Expertise in deviation management, change control, and CAPA • Strong technical writing and document review capabilities • Experience in problem-solving, process troubleshooting, and data analysis • Proficiency with project management tools and data analysis platforms such as JMP and Excel • Excellent communication and organizational skills; ability to manage multiple priorities • 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 • Competitive compensation packages • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects