Associate Director, CMC Program Management

• Jun 2023 - Present

CMC program management to support ADC and small molecule programs from clinical development to commercial stages in oncology and anemia therapeutic areas. CMC program management to support ADC and small molecule programs from clinical development to commercial stages in oncology and anemia therapeutic areas.

Senior Manager, CMC Project Management

• Mar 2022 - Jun 2023

CMC team lead to enable small molecule oncology programs from late discovery to clinical study. CMC planning, vendor management, financial planning, API and drug product development, change management, clinical supply. CMC team lead to enable small molecule oncology programs from late discovery to clinical study. CMC planning, vendor management, financial planning, API and drug product development, change management, clinical supply.

Manager, Technical Operations Project Management

• Nov 2020 - Mar 2022

CMC portfolio and project management of siRNA & mAb programs to treat HBV, supporting quality assurance, quality control, manufacturing, process development, supply chain, analytical & formulation development and regulatory affairs. CMC portfolio and project management of siRNA & mAb programs to treat HBV, supporting quality assurance, quality control, manufacturing, process development, supply chain, analytical & formulation development and regulatory affairs.

Senior Scientist II

• Apr 2018 - Nov 2020

Senior Scientist I

• Sep 2015 - Apr 2018

• Analytical development & QC lead in the CMC team of bispecific antibody and ADC programs under oncology early development.• Analytical R&D (MS, HPLC, CE) to support process development of biotherapeutics, including monoclonal antibodies, antibody drug conjugates and fusion proteins.

Co-Op/Intern

• May 2014 - Dec 2014

Protein drug characterization and quantitation in process development. LC-MS/MS based disulfide linkage mapping of bispecific antibodies. Protein drug characterization and quantitation in process development. LC-MS/MS based disulfide linkage mapping of bispecific antibodies.

Graduate Research Assistant

• Jan 2011 - May 2014

• Developed LC-MS/MS methods to structurally identify N- and O-linked glycoproteins and glycopeptides based on linear ion trap CID and ETD MS/MS data. • Developed and validated a quantitative approach for absolute quantitation of glycoproteins using isotopically labeled internal standards and capillary LC-Orbitrap MS. • Applied bottom-up glycoproteomics methods in analyzing the glycosylation profiles of HIV envelope proteins (gp120 and gp140); performed glycosylation analysis and disulfide bond mapping on monoclonal antibodies (IgG-1). • Designed a software program that interpret MS data to identify glycopeptides automatically. Show less