Principal Engineer, MSAT

🕒 il y a 10 jours

🐎 Kentucky, New Hampshire, +12 états de plus – Distant

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🎸 Mississippi – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote 🧀 Wisconsin – Remote

💵 $157 000 - $174 000 / an

⏰ Temps Plein

🔴 Expert

🧑‍💻 Développeur Full-Stack

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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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 technical execution of commercial-stage comparability strategies supporting site transfers, process, equipment, or material changes • Develop and lead technical workstreams for late-stage and commercial process changes at GMP sites • Conduct technical risk assessments, change controls, impact assessments, comparability considerations, and GMP implementation • Lead late-stage and commercial technology transfer workstreams, including transfer planning, facility/process fit, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness • Own or support technology transfer packages, change controls, technical risk assessments, comparability plans/data packages/reports, process control strategy, execution protocols/reports, batch records, and regulatory source documents • Provide on-site PiP support, troubleshoot process issues, and drive technical investigations, deviations, change controls, and CAPAs to resolution • Establish and evaluate manufacturing data and process performance trends using statistical tools • Identify variability, shifts, and opportunities to improve process consistency, yield, robustness, and compliance • Manage deviation and change-control impact assessments, root-cause analysis, and timely closure of tech transfer investigations • Collaborate with manufacturing sites to ensure technology, equipment, personnel, and documentation support continuous GMP manufacturing • Ensure effective business continuity plans • Serve as a technical and GMP subject matter expert within cross-functional technical execution • Partner with GMP manufacturing sites to transfer and sustain robust, compliant commercial manufacturing processes

🎯 Exigences

• B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required • 10+ years with a B.S.; 7+ years with an M.S.; or 5+ years with a Ph.D. of relevant industry experience • Significant experience in MSAT, Manufacturing, Process Development, or related functions supporting late-stage or commercial biologics or cell therapies • Demonstrated commercial-stage comparability, including comparability supporting manufacturing site transfers, process, equipment, or material changes, or other post-approval/lifecycle manufacturing changes • Demonstrated experience leading late-stage or commercial technology transfer workstreams and working directly with GMP manufacturing sites • Experience with engineering/GMP manufacturing, validation/PPQ, technical deviations, and manufacturing investigations • Experience authoring risk assessments, technical documentation and source documents supporting CMC regulatory submissions • Experience supporting regulatory responses or inspections preferred • Experience leading cross-functional technical subteams and influencing GMP manufacturing partners through complex technical issues and implementation • Cell therapy experience strongly preferred • Experience across multiple commercial manufacturing sites or products a plus • Solid understanding of GMPs, ICH guidelines, and regulatory expectations for cell therapies • Strong knowledge of technology transfer, commercial comparability, GMP manufacturing, validation/PPQ, process control strategy, deviation/change control, and commercial lifecycle management • Ability to independently lead complex technical workstreams, implement commercial lifecycle changes, and develop technical approaches with limited direction • Strong technical writing and document review skills • Strong analytical, troubleshooting, and data-analysis skills • Ability to lead cross-functional technical subteams, influence external manufacturing partners, and mentor junior technical staff without direct management responsibility • Background in cell therapy, viral vector, or other complex biologic modalities with hands-on GMP manufacturing experience preferred • 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 • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages

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