Analytical Development (Mass Spectrometry); *Developed new mass spectrometry based methods for extended characterization of monoclonal antibodies including HPLC, LC-MS, LC-MS/MS, ESI, APCI, and MALDI-MS to support advancing clinical products*Carried out routine cGMP test methods (N-terminal sequencing, C-terminal sequencing, lysine variant analysis, peptide mapping, peptide sequencing) for reference standard qualification and bioequivalence testing*Optimized a current peptide mapping method to reduce sample preparation time by 1.5 days and remove nearly all sample processing artifacts*Authored numerous technical reports, standard operating procedures (SOPs), and standard test methods (STMs)*Designed, carried out, and published work on the origin of pyro-glutamate variants, origin of lysine variants in monoclonal antibodies and investigation and testing for hydrolysate impurities.*Investigated heterogeneity of clinical antibody products (oxidation, glycosylation, deamidation, disulfide bonding, terminal variation) with mass spectrometry in combination with other analytical and biochemical methods including peptide mapping, N-glycan analysis, IEF, SDS-PAGE, and Western Blot*Improved management skills by training and development of a new assistant scientist along with organizing and delegating tasks for multi-researcher projects*Led a project to characterize and identify specific peptide components in a complex hydrolysate used as a feed medium to develop an assay for clearance testing in the final product. *Gained expertise in operation and service of the following instruments: Waters ZQ, Thermo LTQ, Thermo LCQ, Applied Biosystems Q-Star, Applied Biosystems Voyager-DE Pro, Agilent 1100, Waters Alliance 2695, Waters Acquity UPLC, Finnigan Surveyor*Coordinated all service and routine maintenance for the mass spectrometry group (5 mass spectrometers and 8 HPLCs)

*Fully equipped new laboratories for analytical work*Trained three new graduate students in multiple projects*Continued PhD thesis work

Worked in the mass spectrometry facility analyzing samples from various researchers and departments. Utilized MALDI-MS, GC-MS, FAB-MS, and LC-MS for structural elucidation. Interpreted and summarized mass spectral results and conveyed these results to involved graduate students, post-docs, and professors.