Senior Engineer, MSAT

🕒 Agosto 25

🐎 Kentucky, New Hampshire, +11 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

💵 $140.000 - $164.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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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

• Execute and support technology transfer workstreams for late-stage clinical and commercial manufacturing sites • Plan transfers, implement processes, support site readiness, conduct training, and execute manufacturing activities • Execute and support new site and suite readiness assessments, including facility-fit, feasibility, technical, equipment, process, personnel, and documentation assessments • Author and support technology-transfer documentation, protocols, risk assessments, batch records, troubleshooting guides, process playbooks, change controls, and training materials • Collaborate with manufacturing sites and CDMOs to ensure technology, equipment, materials, personnel, procedures, and documentation support compliant GMP manufacturing • Provide on-site Person-in-Plan technical support during feasibility, engineering, GMP, comparability, and validation campaigns • Troubleshoot manufacturing issues and support resolution of technical problems and GMP deviations • Identify and lead continuous-improvement opportunities through risk assessment, change control, transfer-package authoring, and implementation • Implement process knowledge and process-control strategy at receiving manufacturing sites, including CPPs, CQAs, in-process controls, operating ranges, monitoring requirements, and escalation criteria • Establish manufacturing data capture and trending during technology transfer and transition to routine manufacturing • Perform statistical analysis using JMP or similar tools to evaluate process performance, variability, trends, and shifts • Align cross-functionally with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain • Serve as a technical and GMP manufacturing subject-matter expert • Other duties as assigned

🎯 Requisitos

• B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required • 7+ years of relevant industry experience with a B.S.; 4+ years of experience with M.S. or Ph.D. • At least 3+ years of experience in MS&T, Manufacturing or Process Development for biologics/cell therapies • Experience with late-stage clinical, BLA-enabling, or commercial manufacturing activities required • Experience supporting or leading technology transfers for biologics, cell therapies, or other complex manufacturing processes • Experience working directly with CDMOs or external manufacturing sites during technology transfer and/or GMP manufacturing • Solid understanding of cGMP regulations, ICH guidelines, and regulatory expectations for biologics or cell therapy manufacturing • Strong technical writing skills and experience authoring/reviewing protocols, reports, risk assessments, batch records, technical assessments, and source documents supporting regulatory filings • Excellent communication and interpersonal skills • Background in cell therapy, viral vector, or other complex biologic modality with GMP manufacturing and PiP experience • Ability to independently own technical projects and workstreams with minimal day-to-day supervision • Experience conducting or facilitating technical, process, facility-fit, and manufacturing risk assessments using FMEA or similar methodologies • Strong analytical and problem-solving skills and process troubleshooting with a data-driven mindset • Expertise in deviation management, change control, and CAPA • Proficiency with Microsoft Office tools and data analysis platforms such as JMP and Excel • Travel required up to 35% • Candidates must be based in one of the listed states: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, or WA

🏖️ Benefícios

• 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