Amanda Freeman

Background

About Amanda Freeman

More than 20 years of experience working in biotech and pharmaceutical industry specific to drug development. Proficient at enteral and parenteral dosing, animal care and handling, sample collection from small and large animals. Accustomed to working under GLPs, GCPs, GMPs, GDPs and GxPs. Experienced with real-time data collection systems (i.e. Xybion Systems), documentum (i.e. Predi and SubWay) and LIMS. Current position is working as a nonclinical study monitor. Works with CROs to achieve study endpoints and closely follows study timelines. Supports PTRs and various modalities/programs (small and large molecule, siRNA, etc.). Previous position as a Senior Reporting Associate; responsible for compiling bioanalytical data for release to clients (ID, PD, FD), formatting inventory/ reconciliation files for clients, writing and peer review of bioanalytical reports for Mass Spectrometry and Ligand Binding. I possess a strong foundation in nonclinical safety, having worked 8.5 years as a team leader in Toxicology. I managed a team of 7-8 technicians, supervised over in house studies, scheduled daily events, reviewed data, organized data for submission to QA, participated in regulatory audits, responsible for development of technicians, delivered performance reviews, budgeted merit increases based up ratings, and provided technical support when needed. Other relevant experience: formulations prep, antibody production as it pertains to medical diagnostics and system validation.