• Responsible for organizing and directing the Validation staff members that are directly involved in the start-up, commissioning, validation and revalidation activities for GSK Rockville manufacturing facilities• Develop, implement and maintain effective facility, equipment and utility validation programs that support current regulatory requirements for clinical and commercial manufacturing activities.• Support critical process and equipment change controls and manage an effective and efficient revalidation program at all GSK Rockville manufacturing facilities. • Manage the equipment and computerized system change control program to insure that all systems are maintained in a validated state.• Represent validation programs in regulatory settings.• Ensure that the departmental budget is projected and maintained to support annual revalidation and GSK Rockville validation programs.• Serve as a subject matter expert for Facility/Equipment and Utility Systems for GSK Rockville.• Develop GSK Rockville strategies for validation and cGxP compliance through master plans, policies, and procedure generation.• Establish staffing plans and staffing requirements to appropriately meet corporate objectives; recruit and maintain staff capable of achieving goals• Ensures projects are evaluated, planned and implemented within schedule and budget • Perform related support functions as required.

In a Process Development role, developed perfusion process for the production of an HIV-1 immunotherapeutic. Subsequently established the Validation department and procedures. Generated validation master plans (process and equipment), operational SOP's, policies and forms as required. Implemented and validated all equipment and processes used for the production of an HIV-1 Immunotherapeutic.

Performed an independent process development role, accountabilities included; -development of the cell culture process for producing whole killed, gp120-depleted, HIV-1 vaccine in a perfusion bioreactor system.-design, operation, and maintenance of stirred tank, perfusion bioreactors.-validation of all support and process equipment required for upstream processing.