Senior Scientist, Quality Control Operations

🕒 Maio 12

🐎 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

💵 $112.000 - $131.000 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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Aurion Biotech

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2022

🧬 Biotecnologia

💊 Farmacêutico

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

Biotechnology • Pharmaceuticals

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

• Works with external QC laboratories to review and track GMP in process, release and stability testing • Real time review of DP release data during harvests and CoAs as part of a rapid release strategy. • Leads QC data compilation and shares in cross-functional settings. • Able to work with CMO on out-of-specifications and investigations as needed. • Designs DS and DP stability studies, leading to establishment of expiry. This includes protocol review, data review, and report review in collaboration with an external CMO. • Supports technology transfers through data and document review. • Participates in internal and external collaborations to ensure project deliverables are complete and on time by providing team updates and enabling data-driven decisions. • Works collaboratively and cross-functionally to support and implement activities to ensure the project milestones are met. • Be able to help support regulatory personnel with supportive documents related to regulatory filings.

🎯 Requisitos

• MS degree 5+ years’ experience, or a BS degree and 10+ years’ experience in a relevant discipline (cell biology, biotechnology, or related field) in the pharmaceutical industry. • Experience with biological products is critical, experience within cell therapy is preferred but not required. • Working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH, USP, JP). • Experience working within a QC pharmaceutical laboratory. • Experience in lead roles is preferred but not required.

🏖️ Benefícios

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO. • Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work. • Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.