Experience

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  Omrix biopharmaceuticals

  Oct 2006 - Oct 2010

  Research assistant

  Development of innovative product, which included product design and optimizations, test methods development and product characterization. Focused mainly in the fields of hemostasis, spinal reconstruction and healing, and gastrointestinal leaks.

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  Omrix biosurgery israel

  Jan 2011 - now

  - Lead process validation of bulk drug substance and powders manufacturing.- Lead scale up design from laboratory scale to commercial scale. - Lead deviation and CAPA investigation.- Expert in process troubleshooting.- Expert in design of experiments, and statistical data analysis.- Experienced in regulatory audits and respond to observations ( FDA, EMEA,IMOH).- Experienced in lyophilzation cycle design and optimization.- Experienced in product risked management (pFMEA), criticality assessment, process optimization and process yield improvement.- Experienced in combination product development Show less

  • Process Engineering Manager

    Aug 2018 - now

  • process engineer and scale up expert

    Jan 2011 - now
• 

  Omrix biopharmaceuticals

  Sept 2015 - Mar 2022

  Process team lead

  • Managing process engineering team of 3-5 engineers.• Process support for local sites and CMOs• Scale up and technology transfer of biologics products. • Project management