Discovery And Analytical Director
CurrentDiscovery & Analytical Director (2024-Present)• Managed 8 direct reports across 2 departments for quality control, analytical development, and discovery research functions.Associate Director of Discovery (2022-2024)• Led the analytical method development efforts to validate assays according to ICH Q2 guidance.• Led the Mechanism of Action research effort resulting in publication in JTH. Included authoring proposals for funding that were awarded by the Biomedical Advanced Research and Development Authority (BARDA) and overseeing and reporting project deliverables.Senior Scientist (2019-2022)• Planned and executed experiments to characterize Thrombosomes® (human platelets lyophilized by a proprietary methodology), including in vivo model development in NOD-SCID mice, canines, and non-human primates (Cynomolgus).• Project manager for multi-year project sponsored by US SOCOM; this included authoring monthly technical reports, managing the timeline and budget, and communicating status to the client.• Authored stability protocols per ICH Q1A & Q5C guidance and performed stability analysis for Thrombosomes®. Created a stability analysis program in the scripting language R that allowed for rapid analysis and incorporated a user-friendly GUI.Associate Manufacturing and Quality Engineer (2015-2019)• Authored portions of the Chemistry, Manufacturing, and Controls (CMC) section of the Investigational New Drug (IND) submission for a Phase II clinical trial. • Manufactured lyophilized sterile pharmaceutical product for Phase I clinical trials in an ISO class 7 cleanroom according to Good Manufacturing Practices (GMP).• Performed data analysis and trending (SQC) to drive process improvements in the characterization of the product. Led to assay optimization of the aggregation assay and resulted in a lower rejection rate of the final manufactured product.• Wrote and maintained standard operating procedures (SOPs) for manufacturing and quality control processes.
