Yoojung Bae

• Execute routine analytical testing of vaccine process samples to support batch consistency during scale-up operations.

• Validate assay performance by executing repeated runs and assessing data consistency to confirm fitness for intended use.

• Facilitate method transfer and equivalency assessment by benchmarking reagent CoAs and analyzing variability factors to align results across workflows.

• Audit analytical outputs and reconcile calculations, reducing re-analysis to 5% through improved first-pass accuracy.

• Streamline sample tracking by restructuring sample storage and logs in alphabetical order, improving traceability and retrieval efficiency.

• Enforce documentation discipline by maintaining complete records with zero omissions, strengthening internal quality review readiness.

• Quantify enzyme activity using RP-HPLC and analyze chromatographic data to evaluate variant-dependent performance.

• Optimize reaction parameters (e.g., pH, incubation time, buffer composition) to improve assay reliability, achieving 112% activity vs. wild-type under optimized conditions.

• Document raw chromatograms, calculation workflows, and experimental conditions to ensure traceability and structured record-keeping.

• Prepared mutant variants and verified sample quality using SDS-PAGE to support consistent analytical evaluation.