Senior Principal Engineer, MSAT

🕒 il y a 2 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

💵 $180 000 - $202 000 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Aurion Biotech

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2022

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

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

Healthcare • Manufacturing • Biotechnology

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

• 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

🎯 Exigences

• 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%

🏖️ Avantages

• 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