Zurich, Switzerland
I'm an experienced development scientist in the field of biopharmaceutical CMC development having held positions in DSP process development, manufacturing, analytics development and quality control. Furthermore I bring along in-depth knowledge about cGMP, method validation, technology transfer and scale-up.
Manufacturing & GMP specialist - manage & support manufacturing campaigns of clinical trail material (DS, DP) at CMOs - technical process transfer to CMOs and between CMOs - overview of GMP activities and batch data - collaboration with surrounding functions (e.g. QA, technical development, clinical supply)
mAb DSP process expert in regard to commercial manufacturing as well as the transfer of new processes into the site manufacturing plants (GMP ennvironment): - Front line support of commercial mAb production plants (deviations, changes, corrective actions) - Technology transfer of DSP process into commercial manufacturing plants - facility fit for new products - Collaboration with local and global functions (e.g. Q-Unit, process automation, quality risk management, global MSAT, technical development team, regulatory)
General refurbishment in own labor as well as management of supportive work carried out by craftsmen
Responsible for the establishment of all QC related aspects of a transfer- / development project (GMP environment): - establishment, optimization and validation of required analytical methods - release of raw materials, intermediate and end products - setup of stability studies - QC representative in global project team meetings - leadership, support of assigned lab personnel
Hands-on and management of analytical method developments for antibody fragments (scFv), bi-specific antibodyfragments (Db) and pegylated variants thereof: - Method development and qualification (early validation) - Subject Matter Expert for high-throughput analytics - coordination / performance of supportive stability studies - support of method transfers into GMP controlled QC labs (internal / external) - analysis / characterization of IPC, intermediate and end products derived from pilot manufacturing campaigns - technical & scientific support of method users