Principal Engineer, MSAT

🕒 Outubro 20

🐎 Kentucky, New Hampshire, +12 estados a mais – Remoto

🐎 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

💵 $157.000 - $174.000 / ano

⏰ Tempo Integral

🔴 Especialista

🧑‍💻 Engenheiro Full-stack

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Aurion Biotech

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2022

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 $120.000.000 Venture Round - Aurion Biotechnologies em 2022-04

Healthcare • Manufacturing • Biotechnology

A Aurion Biotech é uma empresa em estágio clínico que desenvolve terapias celulares regenerativas pioneiras para restaurar a visão tratando doenças do endotélio corneano e outras causas de cegueira. A empresa se concentra em plataformas de terapia celular em escala de fabricação, utilizando células endoteliais corneanas de doadores humanos combinadas com compostos de apoio (por exemplo, inibidor de rho-quinase) para repovoar o endotélio corneano, reduzir a dependência de tecido doador e possibilitar alternativas menos invasivas à ceratoplastia baseada em enxertos. A Aurion realiza ensaios clínicos globais, possui designações de Terapia Inovadora e RMAT da FDA para seu principal produto AURN001 e visa expandir o acesso a cuidados oftalmológicos avançados em todo o mundo.

Descrição

• 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

🎯 Requisitos

• 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%

🏖️ Benefícios

• 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

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