Experience

Rekah Pharmaceutical Industries Ltd.

• Israel
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QC Microbiology Manager

  • Dec 2021 - Present

• QA Specialist

  • Jun 2021 - Feb 2022

  Annual Product Review (APR) writing Risk Assessment Report writing Elemental Impurities Risk Assessment Nitrosamines Risk AssessmentLab audit

• QA Microbiology

  • Dec 2019 - May 2021

  Technology Transfer Specialist In charge of implantation of Sterility test methods from Rekah site to Vitamed site (work into clean room). Writing of new SOPs and protocols according to change control.Development and validation of microbiological examination for TEVA raw materials used in Septol and Acamoli products.Upgrading all SOP and worksheet used in the microbiological QC laboratory.



Regentis Biomaterials

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Research Assistant

  • Aug 2017 - Sep 2019

  Development of an immunogenicity assay for the FDA regulation (Indirect ELISA). Management of Stability studies of the GelrinC implant. Writing validation protocols of analytical methods, performing the validation and writing reports. Tissue culture Studies of GelrinC effect on metabolism and proliferation of chondrocytes and MSC’s cells. QA Assistant (Raw material inspector): Receiving, testing, qualifying and approving the raw material for GMP production. QC Testing (IPC and Final product): Determination of nitrogen content using Kjeldahl method; Shear modulus determination using Rheometer; Protein content determination using BCA kit; Determination of albumin concentration (albumin ELISA Kit). Show less



InSight Biopharmaceuticals LTD.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• R&D assistant

  • Aug 2016 - May 2017

  Quantitation Assay for monoclonal Antobodies using the Octet PlatformELISA assay

• QC Tissue Culture and Biochemistry Analyst

  • Oct 2014 - Aug 2016

  Cells Biology: routine work in Tissue culture lab with suspension and adherent cells, including split, count using Vi-Cell or hemocytometer, thaw of ampoules and freezing of cell banks.Bioassay experiment : use of live animal (in vivo) and cell culture (in vitro) to determine the biological activity of InSight's drugs.In charge of Drug stability study (schedule, distribution, coordinator of QC lab results).

• QC Biochemistry Technician

  • Oct 2013 - Oct 2014

  Immunoassay experiment: ELISA (from Kit: protein-A, IL-2, HCP and in-house ELISA)Participating in method transfer and implementation of new technology and method from R&D to QC.

• QC Microbiology Technician

  • Aug 2013 - Oct 2013

  microbial detection in water samples by membrane filtration; Detection of bacterial Endotoxin WFI/HPW water; Reading and counting microbiology results in plates.



CEA - Commissariat à l'énergie atomique et aux énergies alternatives

• R&D Research Assistant

  • Jan 2011 - Sep 2012

  Physiopathology studies on prion diseases (Creutzfeldt–Jakob disease, mad cow disease) Histological studies on rodents and primates tissue : immunohistochemistry and immunofluorescence. antigens detection (Prions) in biological tissues. Physiopathology studies on prion diseases (Creutzfeldt–Jakob disease, mad cow disease) Histological studies on rodents and primates tissue : immunohistochemistry and immunofluorescence. antigens detection (Prions) in biological tissues.



INSERM

• France
• Research Services
• 700 & Above Employee

• R&D Technician

  • Oct 2009 - Dec 2009

  PCR and Histologicals studies PCR and Histologicals studies