סקירה כללית
Role Description As the Head of the Analytical Method Development team at NurExone you will: * Lead Analytical Method Development: Develop, optimize, and validate analytical methods for the characterization and specification of exosome-based products. * Develop & Refine Assays: Design and optimize bioassays, immunoassays, and cell-based assays to support product development. * Support Regulatory Submissions: Collaborate closely with the regulatory team to develop methods aligned with FDA and ICH guidelines, supporting IND submissions and early clinical phases. * Engage in Hands-On Laboratory Work: Participate directly in bench work, driving method development, troubleshooting, and ensuring high-quality outcomes. * Communicate with External Partners: Liaise with CROs and external collaborators, ensuring clear communication and alignment on project goals. * Manage the analytical methods team: day-to-day activities, prepare summaries of results and presentations * Report to the Director of R&D: Provide regular updates and detailed reports to the Director of R&D on project progress, challenges, and successes Qualifications * PhD in Biology, Biochemistry, Biotechnology or similar field * 10+ years of industry experience preferably in the exosome or cell and gene therapy/ biotechnology industry- MUST * Extensive experience in analytical method development: FACS, ELISA, NMR/FTIR, qPCR
– MUST * Meaningful Industrial experience, translating R&D to QC
– MUST * Strong understanding of FDA guidelines, particularly related to IND submissions and early-phase clinical trials. * Demonstrated ability to manage multiple projects, prioritize tasks, and meet tight deadlines Personal skills * Critical Thinker: Ability to analyze complex problems, think critically, and develop innovative solutions with an out-of the-box thinking ability to approach challenges from unique perspectives. * Team Player: Strong collaboration and leadership skills, with a focus on working effectively within multidisciplinary teams. * Hardworking & Dedicated: Commitment to working hard, meeting deadlines, and delivering high- quality results. * Proactive, can-do approach, with the determination to overcome challenges and drive projects to completion * Strong communication skills; Fluent in English (written and oral) Company Description We are a dynamic startup company dedicated to developing cutting-edge exosome-based therapies for spinal cord injury. Our innovative approach aims to revolutionize treatment and improve the lives of patients with spinal cord injuries. Join us in our mission to bring transformative therapies to the forefront of medical science.
דרישות המשרה
* PhD in Biology, Biochemistry, Biotechnology or similar field * 10+ years of industry experience preferably in the exosome or cell and gene therapy/ biotechnology industry- MUST * Extensive experience in analytical method development: FACS, ELISA, NMR/FTIR, qPCR
– MUST * Meaningful Industrial experience, translating R&D to QC
– MUST * Strong understanding of FDA guidelines, particularly related t
