Reno, Nevada, United States
A highly advanced, results driven scientific and quality assurance professional. Versatile background that includes expertise in preclinical and clinical bioanalysis (immunology, toxicology and immunochemistry), project management, new business leadership, internal communications, employee training and study direction. A Quality Assurance professional in Good Laboratory Procedure (21CFR Part 58 and Part 11). Achievement in strategy development, corrective and preventative action, inspection resolution and a successful team motivator. A gifted communicator with a proven track record to collaborate successfully with both internal and external clients to produce results.
Scientist in the conduct of assigned clinical and nonclinical research studies (Laboratory Sciences). Includes study management, direct client interactions, scientific mentorship, interpretation and reporting of study data, and assuring the regulatory compliance of these projects. • Serve as a Principal Scientist, Principal Investigator or Project Scientist in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of nonclinical research. • Participate in and coordinate all phases of the study planning process with appropriate departments. • Generate high-quality protocols, amendments, and reports appropriate for assigned studies. • Review, interpret, integrate, and present data on assigned studies. • Function as contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting. • Provide technical and scientific guidance to the research staff. • Attend scientific meetings, conferences and training courses to enhance job and professional skills.
Microscopic analysis of human chromosomes for clinical diagnosis of genomic abnormalities.
Researcher with a focus on the environmental watershed viability of Cryptosporidum Parvum. Publication (under Katherine Leddy): Walker, M.J., Leddy, K.M., Hager, E. (2001) Effects of Combined Osmotic Temperature Stresses on Integrity of Cryptosporidiumparvum oocytes. Applied and Environmental Microbiology