Netherlands
Compliance support of car-t production operation. Performing, coordinating and giving training about root cause investigation. Deviation, capa and change control ownership and management. Active participation and role in internal audits and regulatory inspection. Implementing changes for clinical and commercial production. MSAT member of value stream map project of deviation end-to-end process.
Technology transfer from development to external manufacturing sites (CMOs). Manufacturing of vaccines for clinical development stage. Purpose: realization of drug product process at large scale.
Technology transfer from development to production. Manufacturing of monoclonal antibody as part of biosimilar pipeline. Purpose: establishment of drug substance large scale process.
Technology transfer from manufacturing to manufacturing site (US to Hungary). Manufacturing of conjugated monoclonal antibody as part of a new site start-up. Purpose: launch research reagent production at bench scale. BD Biosciences
Technology transfer between two manufacturing sites. Manufacturing of derivatised bacterial toxoid as part of a new facility start-up. Purpose: launch vaccine carrier protein production at large scale. GSK Vaccines
Technology transfer from Singapore to Hungary. Manufacturing of derivatised bacterial toxoid as part of a new facility start-up. Purpose: launch vaccine carrier protein production. GSK Vaccines
Global Industrial Operations graduate program 4° Assignment | Hungary: Production - Process development 3° Assignment | Singapore: Production - Vaccines primary operations 2° Assignment | Belgium: Supply Chain - Customer Interface 1° Assignment | Hungary: Quality Assurance - Technical Validation