Experience

MediWound

• Israel
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, pharmaceutical & non-clinical development

  • 2023 - Present

  o Head all preclinical activities and formulation development up to commercial production.o Lead several parallel programs including collaborations with the US government and Department of Defense. o Direct management & management of CROs and CMOs

• Head of pharmaceutical & non-clinical development

  • 2020 - 2023

  o Defining TPP, leading formulation development, tech-transfer and scale up to GMP manufacturing (utilizing QbD principals)o Leading non clinical studies- pharmacology and toxicology, TK and ADA (GLP)o Managing the development of a biological drug for emergency use, according to FDA animal rule (approval of a drug based on animal studies without human clinical trials). The project is funded by a U.S. federal Authority (BARDA)o Providing scientific evaluation in due diligence processes and assessing new technologies and business opportunitieso Participating in regulatory submissions and meetings with FDA and EMA, including BLA Show less

• R&D project manager

  • 2013 - 2020

  o Managing CMC and pre-clinical CRO’s, including pharmacology and toxicology, TK and ADA (GLP)o Responsible for the coordination between the different departments: pre-clinical, clinical, medical, production, operations, regulation and QA. o Managing scientific projects exploring the mode of action of the APIo Developing unique primary packages (with a packaging manufacturer) o Writing and submitting global patents



Procore ltd

• Nes Ziona Israel

• Project manager

  • Jan 2011 - Sep 2012

  Developed polymer and protein-based membranes as functional materials in bio-medical devices such as orthopedic implants and skin grafts. Developed polymer and protein-based membranes as functional materials in bio-medical devices such as orthopedic implants and skin grafts.