Senior Scientist, Quality Control Operations

🕒 May 12

🐎 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

💵 $112k - $131k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🧬 Biotechnology

💊 Pharmaceuticals

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Biotechnology • Pharmaceuticals

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

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.