Leo Brenman Email & Phone Number

Israel

•Leading Extractables and Leachables & Nitrosamines Risk AssessmentsLeading the Implementation of EU Medical Device Regulations -MDR•Review & Implementation of Guidelines, Pharmacopeia chapters, ISO standards and corporate procedures•Writing The Annual Site Quality Review, Preparing the Annual Management Review & QRB, Product Quality Reviews, Technical/Quality agreements and QMS Quality Procedures•Internal Auditing and Vendors and Contract facilities Auditing Abroad

• Implementation of Capillary Electrophoresis Technology• Implementation and Validation of Container Closure Systems• Responsible for Evaluation of Extractables & Leachables from Product Contact Materials

Israel

Managing the Chemistry Unit Laboratory• Development, production and analysis of oral dosage form drug products for clinical trials.• Stability and Compatibility Studies on drug substances & drug products• Development and Validation of Analytical & Bioanalytical methods for drug substances and drug products• Outsourcing Managment - Supervise drug substance & drug product manufacturing, analytical and bioanalytical method development for the analysis of pharmaceuticals at subcontractor's facilities• Preparation of documentation required for clinical trials and audit of clinical sites• Acquaintance with FDA guidelines, CMC preparation for IND submission, GMP, GLP, and RA issues

Israel

• Management of projects and tasks in the field of product process development and product analysis• Development and validation of analytical methods for protein analysis• Provide scientific expertise and support in solving Quality Control and production issues (trouble shooting)• Validation of drug product shipment and storage conditions• Technology transfer to internal departments and sites abroad (QC and Production)• Execute work procedures, protocols and reportsEnvironmental Management System (EMS) Manager according to the ISO14001 standard ( Managing all of InterPharm’s environmental activities)

M.Sc In Chemistry, Analytical Chemistry

Bachelor Of Science - Bs, Chemistry