Jacek Stadnik

Quality And Regulatory Affairs Director

Jacek joined BIOTON in 2018 as a Chemistry, Manufacturing and Control Expert (CMC Expert), and then developed his career by taking up the following functions: Quality Control Manager, Senior Quality Control Manager, up to the position of Quality Director, which he has held since 2022. Since 2023 Jacek has been leading Quality And Regulatory Affairs Department.

A graduate of chemistry faculty at the Maria Curie-Skłodowska University in Lublin. His passion is chemical analyzes, especially concerning medicinal products of biotechnological origin. At BIOTON, he is responsible for quality processes (quality assurance and quality control) in all areas covered by Good Manufacturing Practice as well as all regulatory processes for medicinal products and medical devices.

Since 2019, as the only representative of the Polish biotechnology industry, he represents our country in the European Directorate for the Quality of Medicines (EDQM), being a member of the Expert Group No. 6, where he issues opinions on draft changes to the European Pharmacopoeia monographs concerning biological and biotechnological active pharmaceutical ingredients and drugs.