Year: 2018-19

Company: Gilead Sciences, Inc.

Liaison(s): Gerard Jensen, Thomas Upton

development, and commercialization of innovative medicines in areas of unmet medical need. Founded in 1987 and headquartered in Foster City, California, Gilead’s portfolio and pipeline includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions. Gilead’s new La Verne, CA site, where the Team Master’s Project is focused, is responsible for manufacturing AmBisome®, packaging and labeling antiviral products, as well as distributing products to the Americas and Pacific Rim.

To ensure the manufacturing processes at the new site in La Verne remain in a state of control, Gilead’s Technical Services (TS) department asked the TMP team to assist with the development and implementation of a Process Information Management System (PIMS).

The Gilead TS TMP team first conducted a comprehensive assessment of the current AmBisome manufacturing processes to identify any gaps or areas for improvement in the system. Once identified, a business proposal was developed for additions to the existing Plant Information (PI) System. Once the business proposal was approved, the team began analyzing SMART tags associated with human-machine interfaces (HMIs) of the manufacturing equipment. The latter half of this project focused on the main objectives of creating a website resource exclusively for Gilead TS containing training materials on how to use PI System client tools, drafting the change control document for some of the PI System upgrades, and identifying the critical data that could be displayed on screens throughout the TS offices to assist in real-time monitoring.