Kessler Consulting provides quality services for Biopharmaceutical, Drug and Combination Product development and manufacturing. We specialize in establishing product development strategy, establishing and improving quality systems to meet FDA and EU CGMP and regulations, finding optimal solutions to overcome regulatory issues that may arise during product development and licensing, preparing companies for FDA and EU regulatory inspections and helping companies to manage their regulatory inspections.CLIENTS:Ayana Pharma Ltd.Alcobra Ltd.Biotechpharma UABAH, LithuaniaImmunarray Ltd.Integra Holding Ltd.Israel Ministry of HealthKamadaTeva

• Responsible for Quality Operations in Teva Plants located in Israel, Germany, Lithuania and Mexico.• Responsible for QA oversight of CMOs located in the US, Germany and Lithuania, manufacturing and/or developing biopharmaceutical and finished drug product for Teva. • Served as a Subject Matter Expert in Sterile Operations. • Coordinated implementation of lean management activities within plant quality operations. • Head of Quality operations for the Teva Biopharmaceutical Operations Network- which was responsible for late stage development and licensure of the Teva biosimilar and new entity biopharmaceutical products. • Responsible for Quality oversight of OSD, Large Volume Parenteral, Small Volume Parenteral, Medical Device Biopharmaceutical API plants located in Israel.

SENIOR VICE PRESDIENT, QUALITY | KAMADA | 2003-2010Senior Quality Officer at Kamada, Ltd (NASDAQ KMDA). Was responsible for rebuilding Kamada’s quality system and operations to meet the US FDA and EMA cGMP regulations for the manufacturing and control of biopharmaceutical blood products. This entailed the following:• Revision of all quality operations and controls for their manufacturing processes• Design and commissioning of new QC Laboratories• Revision and upgrading of QC test procedures and their quality oversight• Oversight of the design upgrade, building and commissioning of their API and finished drug manufacturing plant to meet FDA standards for a blood product manufacturing plant• Implementation of a pharmacovigilance policy and procedures• Restructuring of their Regulatory Affairs departmentPlayed a central role in the development and licensure of KamRAB (human rabies immune globulin) in the EU and other markets and for the development and licensure of Glassia (for the treatment of Alpha 1 Anti-trypsin deficiency) for the US market.

Served a number of roles of increasing responsibility within the Company:• Senior Scientist in the R&D Department (management and renewal of a 10 million dollar contract to produce HIV research tools for the US National Institutes of Health). • Senior Quality Assurance Scientist. • Head of Quality Control Department, • Manager of Quality Control and Quality Assurance Units• Vice President Quality, reporting to the Corporate Head of Quality.Responsible for all quality operations associated with the development and production of biopharmaceutical API, drug products and medical devices for clinical studies and marketing in the US, Europe and other countries across the globe. Responsible for the Quality oversight for the design and commissioning of a new manufacturing plant for the production of biopharmaceutical APIs (bacterial and mammalian expression systems) and the aseptic production of a prefilled syringes