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