• Lead analytical development team in transferring/developing/qualifying analytical methods insupport of CMC development of clients’ products.• Drive technology innovation and development of analytical platforms applied to evaluation of thephysicochemical and biological attributes of a wide variety of molecules and modalities.• Manage and support client and internal partner interactions.• Review potential clients’ RFPs and provide plans for analytical development activities and FTEestimates to be included in proposals/contracts.• Direct the drafting, integrity and review of data, methods, development reports, qualificationprotocols/reports, and department procedures.

• Lead Analytical Chemistry, Analytical Characterization and Bioassay Development groups tosupport pipeline projects from early clinical phase to commercialization.• Direct analytical development activities in selecting, developing, and qualifying phase-specificanalytical methods to characterize critical quality attributes (CQA) and to establish releasespecifications for drug substance and drug product, as well as in-process controls. IncludingHPLC/UHPLC (SEC, IEC, RP, glycan, polysorbate, process-impurities), CE-SDS, CIEF, LC-MS(peptide mapping, intact mass, PTM, glycosylation, sequence variants), UV/Vis Spectroscopy,SDS-PAGE, ELISA (target binding, HCP), cell-based potency assay (proliferation, inhibition ofproliferation), SPR, and qPCR (host-cell DNA), etc.• Oversee QC assay transfer and provide support for quality events such as OOS and CAPA.• Support cell line development, upstream process development, downstream process development, formulation development, as well as QC control strategy development including reference standard qualification and establishment of release specifications.• Supported process characterization (PC) and process performance qualification (PPQ) activities with providing high-quality and timely analytical testing services.• Led cross-function teams (analytical development, formulation development, QC) in planning similarity characterization projects, oversaw execution of similarity characterization studies for successful similarity assessment.• Authored selected Module 3 CMC sections of BLA for a monoclonal antibody biosimilar product. Contributed to successful FDA pre-license inspections (PLI).• Coordinated and oversaw outsourced projects.• Manage the team and oversee their performance management, support individual growth and career development while developing team capabilities.

• Developed CE - top down MS platform to analyze intact proteins from Pyrococcus furiosus• Characterized the yeast Dam1 complex subunits and measured phosphorylation stoichiometry of each subunit upon Mps1 kinase treatment with CE - top down MS strategy; identified phosphorylation sites of each subunit with top down, bottom up and middle down MS approaches • Characterized various post-translational protein modifications (PTMs) such as phosphorylation, glycosylation, disulfide bonds, acetylation, arginylation, nitrosylation, oxidation with bottom up and top down mass spectrometry approaches• Developed a simple, robust platform enabling proteome-wide, label-free quantification and facilitated the study of the mechanism of action for the cancer therapeutic drug bortezomib in HEK 293T cells• Established the focal adhesion proteome under steady state and myosin II inhibition using label-free quantitative proteomics strategy• Defined human salivary gland proteome using both bottom up and top down mass spectrometry• Assisted in software development of Census, XDIA, YADA, ProteinInferencer

• Developed top down MS techniques including NSD for analysis of much larger proteins (>200 kDa)• Characterized various enzyme modifications on recombinant proteins and protein disulfide folding intermediates • Characterized profiles of phospholipids of detergent-resistant membranes from RBL mast cells