CMC Project Leader; Led biochemical and biophysical groups

Lead a group of scientists supporting late phase analytical development. Responsible for phycicochemical characterization, biophysical testing and stability testing.

Head of Biophysical Research and Analytical Development. The BRAD group is responsible for lead candidate characterization and Due Diligence and assists in the Early Drug Discovery effort

Innovation and Technology Lead for Analytical Dev.Responsible for the identification, evaluation and implementation of new analytical techniques and novel technology platforms.

Early Phase Characterization/ Cell Culture AnalyticalSupport Group Leader/HTS SupportProduced oligosaccharide analysis (peak ID, characterization, and linkage analysis) for BLA filing of 2 phase III projects.Implemented integrated HTS analysis in Cell Biology, Purification, and Formulation groups.Built Java thin client server program for analysis of data.Member of Innovation Project Board.Hired group members and set-up new group.Responsible for method development and validation of assays used in BLA filings.Characterization methods Peptide MappingIntact MassLinkage analysisOligosaccharide mapping Monosaccharide analysis. Managed junior staff.Developed HTS methodology for product characterization.Initiated automated sample preparation and analysis methods for intact molecular weight, peptide mapping and oligosaccharide mapping.Member of Innovation Project Board and Innovation Champion.2006 to; Early Phase Characterization/ Cell Culture AnalyticalSupport Group Leader2005 to; Carbohydrate group leader/Cell Culture Analytical Support Group Leader. Hired senior staff for Cell Culture Analytical Support and set-up group.Managed junior and senior staff.Characterization methods for cell culture and oligosaccharide analysis.Member of Innovation Project Board and Innovation Champion.Member of several CDT teams and teams focused on outside technology development.Research Scientist- Methods Development Analytical representative for CMC teams.Responsible for method development and validation of assays used in BLA filings for late phase projects.Method development of: peptide maps, forced degradation studies, aggregate assays.

BioAnalytical Characterization Design, develop, and implement HPLC and MS strategies for characterization of monoclonal antibodies (NMEs to commercial products). Methods of analysis included carbohydrate linkage(MSn), peptide mapping(LC-MS/MS), oligosaccharide mapping(LC-MS/MS), deamidation and oxidation monitoring(LC-MS), and CID sequencing of intact proteins, peptides, and glycopeptides. Provided characterization data [peptide mapping [LC/MS], oligosaccharide mapping, disulfide mapping, etc; for technical memos, IND and BLA filings for NMEs and clinical projects.Supervised junior staff within BAS. Developed an oligosaccharide mapping method and linkage analysis method. Developed a peptide mapping and deamidation method.