Senior Engineer, Purification Development
South San Francisco, California, Us
Purification Process Development Molecule Lead• Lead a 3 person team in purification process development, scale-up, support of clinical manufacturing, and purification Initial New Drug Application (IND) section authoring for a moleculePurification Robotics & Modeling Team• Leveraged mass spectrometry and robotics for high-throughput proteomic identification of prevalent hydrolytic and hazardous host cell proteins. Identified 12 potentially problematic co-purifying host cell proteins (protolytic, hydrolytic, immunogenic, etc) as candidates for further study.• Supported development and validation of a Gibbs-Donnan effect model in python describing volumetric exclusion and non-ideal pH equilibria in protein formulation, and leveraging homology models for antibody charge. The model, validated with historical data, was submitted to the FDA in-place of experimental process validation data. (see publication)• Developed a Bayesian strategy for chromatogram peak deconvolution to improve integration accuracy in accelerated high-performance liquid chromatography assays (patent pending)Process Analytical Technology Global Strategy Team• Developed a strategy to identify small molecules by comparing experimental Raman spectra with a library of spectra predicted by density functional theory, supporting an FDA request for point-of-use ADC toxin identity testing in an ADC manufacturing process (patent pending). • Developed a high-throughput automated workflow for sample preparation and spectral collection to streamline and debottleneck machine learning dataset generation for Raman spectra.
