Senior Principal Engineer, MSAT

🕒 Agosto 4

🐎 Kentucky, New Hampshire, +10 estados a mais – Remoto

🐎 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

💵 $180.000 - $202.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

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 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

🎯 Requisitos

• 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%

🏖️ Benefícios

• 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