•Developed identification and quantification assays using HPLC and Mass spectrometry crucial for the submission of an FDA biologics application license
•Trained junior team members in routine assay performance as well as assay development, helping to promote a team culture of collaboration as well as innovation and self sufficiency
•Implemented highly specific Good Manufacturing Practices, FDA regulations, and International Conference on Harmonisation guidelines into assay development to ensure smooth transitions into manufacturing and production
