Mindaugas Katkus
Qualified Person
Pharmaceutics
biotech pharma
Lithuania
Biography
Education: Master Degree in Biochemistry, Manager of Technologies diploma Professional Experience: Has over 16 years experience in the pharmaceutical (large volume parenterals) and biopharmaceutical industry at different management positions: Head of Quality Control, Head of Validation, Senior Validation Engineer and Quality Assurance Manager. Ten years has worked in SICOR Biotech TEVA. Has expertise in analytical methods for biologicals and requirements applicable for centralized registration of biosimilars in EU by EMA, BLA (FDA), TGA, ANVISA (Brasil), PMDA (Japan), Ukraine, Russia and other countries; transfer of methods and technologies. Experienced in external audits, audits of contract manufacturing activities, laboratories and due diligence.
Research Interest
Pharmaceutics