Senior Scientist, Quality Control Operations

🕒 il y a 29 jours

🐎 Kentucky, New Hampshire, +10 états de plus – Distant

🐎 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 / an

⏰ Temps Plein

🟠 Senior

⚙️ Opérations

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Aurion Biotech

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2022

🧬 Biotechnologie

💊 Pharmaceutique

💰 €120 000 000 Venture Round - Aurion Biotechnologies en 2022-04

Biotechnology • Pharmaceuticals

Aurion Biotech est une entreprise au stade clinique qui développe des thérapies cellulaires régénératrices de premier ordre pour restaurer la vision en traitant la maladie endothéliale cornéenne et d'autres causes de cécité. L'entreprise se concentre sur des plateformes de thérapie cellulaire à l'échelle de la production, utilisant des cellules endothéliales cornéennes de donneurs humains combinées à des composés de soutien (par exemple, un inhibiteur de la kinase rho) pour repeupler l'endothélium cornéen, réduire la dépendance aux tissus de donneurs et permettre des alternatives moins invasives à la kératoplastie basée sur les greffes. Aurion mène des essais cliniques mondiaux, détient les désignations de thérapie innovante et RMAT par la FDA pour son principal produit AURN001, et vise à élargir l'accès aux soins ophtalmologiques avancés dans le monde entier.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.