Experience

ImPact Biotech

• Israel
• Biotechnology Research
• 1 - 100 Employee

• Senior QA Associate

  • Jan 2023 - Present



Galmed Pharmaceuticals Ltd.

• Israel
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• CMC leader

  • Jun 2021 - Sep 2022

• Director Of Quality Assurance

  • Dec 2019 - Sep 2022



Atox Bio

• United States
• Biotechnology Research
• 1 - 100 Employee

• QA Director

  • Apr 2018 - Nov 2019

  • Establish, implement and maintain Quality systems to support clinical manufacturing, testing and regulatory processes. • Assist in the writing and/or reviewing of SOPs quality documentation and review various documentation such as regulatory submissions, protocols, reports, batch records, deviations, corrective/preventive actions to reported audit observations, and ensure proper follow-up documentation is created. • Monitor employees training programs • Perform on-site GMP/ GLP compliance audits to CMC vendors and internal audits in Atox Bio. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Chemical and CMC project leader

  • Sep 2005 - Mar 2018

  My job included leading all related issues of the chemical development of an innovative drug looking for the best (quality, yield) process for production scale. Follow up on research and manufacturing process and writing/ review all related documentations (including development reports, relevant submission (RA) part, justification documents, IP). Where needed, tasks and documentations were prepared in accordance to cGMP regulations.The project leading could be on tasks done either in-house or by CROs/ CMOs. As a CMC leader, I have planned and coordinated the CMC development activities in the various CMC disciplines, including chemical analytical and pharmaceutical development.As a project leader in Pharmaceutical operations department (recently assigned), I have reviewed DP regulatory submissions, production, analytical and stability documents and participated in planning production/validation campaign for biological and small molecule drug products. Show less

• QA Manager

  • Mar 2003 - Sep 2005

  The scope of this job was to upgrade and harmonize the QA work in all the Teva API sites in accordance to the regulatory guidelines and perform internal audits.

• API Chemical R&D, Researcher

  • Mar 1995 - Mar 2003

  Development of chemical synthesis routes for generic drug substance