Analytical, strategic, and technical consulting for the Biopharmaceutical Industry• Developed analytical characterization strategy for biopharmaceutical development• Troubleshooting for complex biologic product development • Provided support for Product Development Project Management • Clients: TSI, CANbridge Life Sciences

• Established CMC operations and negotiated manufacturing contracts• Developed CMC strategy for veterinary monoclonal antibody therapeutics• Analyzed COGs and set manufacturing process targets• Streamlined CMC development for efficient pathway to commercialization

• Established and built Development organization• Negotiated contracts and timelines with external manufacturing and development partners• Developed strategy for managing development of multiple therapeutics• 3 IND submissions in 2 years• Managed out-sourced CMC development and manufacturing for product portfoli

• Developed strategy for analysis and characterization of a biosimilar candidate.• Contributed to authorship of briefing book for FDA type II meeting - both overall similarity strategy and analytical development data• Managed GMP operational readiness at CRO/CMOs• Coordinated high throughput analysis and characterization in support of Process Development and Cell Line Development activities• Managed CRO analytical development and cell line development • Established outside collaborations with CROs to evaluate new technologies and add new capabilities.• Presented data in both oral and poster formats at multiple national and international meetings• Managed 9 reports including M.S. and Ph.D. scientists

• Lead a team of Ph.D., M.S. and B.S. scientists• Contributed to multiple IND filings• Promoted presentation of work by team members at national meetings• Contributed to strategic CMC planning• Facilitated transfer of analytical release and characterization methods to partners and internal QC groups

• Built and managed Analytical Development team• Developed analytical methods for characterization of Fc-fusion proteins to treat Muscular Dystrophy, Multiple Myeloma and Bone Loss• Developed characterization methods for elucidation of carbohydrate structures in biotechnology products• Biophysical characterization of protein therapeutics

• Developed methods for analytical characterization of protein-drug conjugates• Biophysical characterization of protein drug conjugates• Developed Phase I and Phase III formulations for protein-drug conjugates

• Characterized phospholipid - protein interactions using BiaCore and light scattering• Purified and characterized protein drug products using SDS-PAGE, HPLC, BiaCore, light scattering, Mass Spectroscopy, N-terminal sequencing, peptide mapping• Characterized various protein formulations for stability using HPLC and cellular activity assays• Supervised other team members

• Contributed to characterization of INFUSE® Bone Graft• Developed a PEG-protein conjugate and tested efficacy in vivo• Evaluated different drug delivery platforms for controlled release of a protein• Characterized protein stability using HPLC and cellular activity assays• Initiated development of a binding assay to screen for active compounds

• Investigated existing and novel biopolymers for tissue engineering and drug delivery.• Produced and purified protein growth factors on a laboratory scale• Collaborated on an interdisciplinary islet transplantation project.