Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company that aspires to transform the treatment of rare diseases in immunology, hematology, metabolic and lysosomal storage disorders
•Performed analytical biochemistry techniques on routine and non routine drug samples for rare diseases to support in process, release and stability stages in a good manufacturing practice (GMP) environment
•Conducted laboratory experiments with strict adherence to industry standard operating procedures (SOPs) to ensure compliance with quality measures
•Experienced with FDA audits
•Executed method qualification projects and validation assays
•Tracked trend analysis of experimental data results and opened deviations / aided in CAPAs accordingly
•Troubleshot testing methods with team to ensure accuracy and increase efficiency, and aided in SOP revisions
•Integrated chromatograms and accurately analyzed and documented assay results
•Mastered new technical procedures via virtual modules weekly
•Conducted training as a qualified trainer (QT) for new hires on laboratory operations, techniques, and instruments
•Assays performed: High Performance Liquid Chromatography (HPLC) - Size Exclusion (SEC), Reverse Phase (RP), CTERM, TITER, Ion Exchange (IEX); A280; Potency; Appearance; Osmo; Activity, etc.
•Software / Systems: LIMs, Waters Alliance, Empower, Statistica, Trackwise, Veeva Systems, SABA, Microsoft Suite, Teams, Office, Excel