Over the past 25 years, I have enjoyed a progressive career with fortune 500 pharmaceutical company in the area of Analytical Chemistry in the R&D environment. My experiences have been in all areas of the pharmaceutical development process, with specialization in development and validation of CMC methods. I have been responsible for the management of developmental stability studies as well as quality control testing of clinical supplies. My responsibilities have included management of the laboratory cGMP compliance as well as scientific and quality review and approval of clinical supplies manufacturing batch records. I was also responsible for the monitoring, evaluation and closure of investigations. I have collaborated with QA in the evaluation of our quality systems which has resulted in redesign and issuance of procedures, processes and third party quality agreements.

At the same time, I have been very instrumental in justifying and implementing multiple global computer systems. In addition to selection, configuration, validation and deployment of computer systems in a regulated environment, I have significant experience in creating standard operating and backup procedures and training material.

I have greater than 10 years experience managing work, personnel and operating budgets with a track record of delivering high quality work on budget and on time.