Bioanalytical Lab Manager with extensive experience in establishing and managing bioanalytical GLP lab to support non-clinical and clinical (Bioequivalence) studies.
Exceptional interpersonal and communication skills with demonstrated supervisory and leadership qualities in managing reports.
I am a bioanalytical Scientist with experience in development and validation of new methods for detection of drugs.
Thorough understanding of drug method development and operations with diverse experience in bioanalytical assays, lab automation, and GLP contributed to multiple patents and scientific publications in a manager or individual contributor role.
I possess a strong knowledge of the Regulatory requirements for Bioanalytical Development including knowledge of the FDA and EMEA guidances, and GLP practices for the validation of methods and reporting of results. I have developed Bioanalytical Report templates along with Validation Report templates and used these templates to report results in new drug submissions.
In addition, evaluation of bioanalytical result data to estimate pharmacokinetic and statistical parameters by using WinNonLin and SAS software.
Analytical Lab Manager
International Center for Bio-availability, Pharmaceutical, and Clinical Research (ICBR)
October 2011 - /
ICBR emerged as a Contract Research Organization (CRO) guided by years of experience, and motivated to excel all aspects of clinical research. ICBR is determined to put Egypt on the map of global clinical, scientific and ethical research, in line with local, regional, global regulations and in house quality.