לא צויין
נקבה
לא צויין
****
אין פרטים זמינים
אין פרטים זמינים
מקצועית, תואר ראשון
עברית
אנגלית
אין פרטים זמינים
אין פרטים זמינים
BrainStorm cell therapeutics
Process Development Manager 2022- Present
Manage and provide guidance to technicians and scientists in the group.
Lead internal development projects and manage technology transfer including implementation of R&D project in
manufacturing facility in compliance with to cGMP and cGLP guidelines.
Develop project plans, generate, and review documentation, and provide updates to management.
Design and lead projects to increase product yield and provide troubleshooting when necessary.
Provided regular operational updates and strategic overviews to senior management, ensuring transparency and
alignment with business objectives
Process Development Associate 2021-2022
Create, revise and review protocols, analytical data, and reports for method validation, testing, and release of raw
materials, drug products and intermediate products.
Manage the integration of the current production process into bioreactors, including upscale from CellStacks.
Performing Real time PCR, ELISA and Flow Cytometry in development studies.
Implementing a Priority System for effective inventory management, orders and receipt of goods.
Interim Manufacturing Manager 2020-2021
Led the setup of a new manufacturing site including hiring and training of new personal.
Collaborated with cross-functional teams to ensure a smooth transition and integration of the new site.
Implemented new equipment including oversight of IQ/OQ/PQ and the development of operational procedures,
providing necessary training.
Directed day-to-day manufacturing operations, managing a team of 5 employees, scheduling activities, and ensuring
alignment with project timelines.
Acted as primary liaison with CDMO partners, ensuring effective communication, and clear expectations
Manufacturing and QC Associate 2016-2021
Contributed to the production team in manufacturing of clinical and qualification batches in a GMP clean specializing
in the handling of cultured mesenchymal stem cells (from Bone marrow to product).
Reviewed and approved QC test results and raw data issued Certificates of Analysis and conducted development and
stability studies.
Drafted, reviewed, approved, and implemented Standard Operating Procedures (SOPs) and forms as required.
Oversaw Contract Laboratories ensuring effective communication and mutual understanding of testing and reporting
requirements.
Facilitated Technology Transfer to two US CMOs and supervised clinical trial phase III.
M.Sc. Structural and Molecular Biochemistry 2015-2016
Hebrew University
Biology and Chemistry
Process Development and Operations professional with 9+ years of experience in biopharmaceuticals, specializing in the
development, manufacturing, and regulatory documentation of drug products, technology transfer, regulatory compliance, and
cross-functional project leadership. Extensive background leading projects through Phase III clinical trials, supporting regulatory
submissions, managing CMOs/CROs, and driving process optimization in compliance with FDA, ICH, cGMP, and cGLP guidelines.
