Senior Engineer, MSAT

🕒 il y a 2 mois

🐎 Kentucky, New Hampshire, +11 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

💵 $140 000 - $164 000 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 11%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

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

• Execute and support technology transfer workstreams for late-stage clinical and commercial manufacturing sites • Plan transfers, implement processes, support site readiness, conduct training, and execute manufacturing activities • Execute and support new site and suite readiness assessments, including facility-fit, feasibility, technical, equipment, process, personnel, and documentation assessments • Author and support technology-transfer documentation, protocols, risk assessments, batch records, troubleshooting guides, process playbooks, change controls, and training materials • Collaborate with manufacturing sites and CDMOs to ensure technology, equipment, materials, personnel, procedures, and documentation support compliant GMP manufacturing • Provide on-site Person-in-Plan technical support during feasibility, engineering, GMP, comparability, and validation campaigns • Troubleshoot manufacturing issues and support resolution of technical problems and GMP deviations • Identify and lead continuous-improvement opportunities through risk assessment, change control, transfer-package authoring, and implementation • Implement process knowledge and process-control strategy at receiving manufacturing sites, including CPPs, CQAs, in-process controls, operating ranges, monitoring requirements, and escalation criteria • Establish manufacturing data capture and trending during technology transfer and transition to routine manufacturing • Perform statistical analysis using JMP or similar tools to evaluate process performance, variability, trends, and shifts • Align cross-functionally with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain • Serve as a technical and GMP manufacturing subject-matter expert • Other duties as assigned

🎯 Exigences

• B.S., M.S., or Ph.D. degree in a scientific or engineering discipline required • 7+ years of relevant industry experience with a B.S.; 4+ years of experience with M.S. or Ph.D. • At least 3+ years of experience in MS&T, Manufacturing or Process Development for biologics/cell therapies • Experience with late-stage clinical, BLA-enabling, or commercial manufacturing activities required • Experience supporting or leading technology transfers for biologics, cell therapies, or other complex manufacturing processes • Experience working directly with CDMOs or external manufacturing sites during technology transfer and/or GMP manufacturing • Solid understanding of cGMP regulations, ICH guidelines, and regulatory expectations for biologics or cell therapy manufacturing • Strong technical writing skills and experience authoring/reviewing protocols, reports, risk assessments, batch records, technical assessments, and source documents supporting regulatory filings • Excellent communication and interpersonal skills • Background in cell therapy, viral vector, or other complex biologic modality with GMP manufacturing and PiP experience • Ability to independently own technical projects and workstreams with minimal day-to-day supervision • Experience conducting or facilitating technical, process, facility-fit, and manufacturing risk assessments using FMEA or similar methodologies • Strong analytical and problem-solving skills and process troubleshooting with a data-driven mindset • Expertise in deviation management, change control, and CAPA • Proficiency with Microsoft Office tools and data analysis platforms such as JMP and Excel • Travel required up to 35% • Candidates must be based in one of the listed states: IN, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, or WA

🏖️ Avantages

• Full health insurance for employees and their families • 401(k) matching • EAP • FSA • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages

📊 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