Eva Hellström Email & Phone Number

Stockholm County, Sweden

Stockholm, Stockholm County, Sweden

Stockholm, Sweden

Team lead for a cross-functional product team responsible for ensuring continuity in supply. The team handles supply planning, quality related questions, technical and regulatory activities for drug substance, drug product and finished goods. Activities also included are line extensions and launches in new markets.Responsible for interactions with partners and contract manufacturing organisations (CMOs), such as coordination of activities, business management, supply agreements.

Stockholm, Sweden

Responsible for technology transfer of a commercial protein purification process to a new CMO including documentation transfer, set up of the purification process, full scale validation batches and compilation of CMC documentation. Subject matter expert for purification processes handling eg CMC documentation, change controls, deviations, APR/PQR.Managing pilot scale purification of material for toxicological and clinical trials; transfer of process from process development, setting up chromatography, UF/DF and filtration steps, compiling risk assessments, process descriptions and batch records.

Stockholm, Sweden

Responsible for validation of a new plasma protein purification facility including performance of product validation. Team leader for installation and validation of a new freeze dryer. Performing cleaning validation, deviations investigations, handling change control errands and writing SOPs.