Company: Gilead Sciences
Liaison(s): Steven Brannan, Chris Deitz, Fred Kilpatrick, Catherine Kuo, Mark Nelson
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead was founded in 1987 in Foster City, California. Over the past 25 years, it has grown to become one of the world’s largest biopharmaceutical companies, with approximately 6,000 employees across five continents. Gilead has a portfolio of products and a pipeline of investigational drugs directed at therapies for HIV/AIDS, liver diseases, serious respiratory and cardiovascular conditions, cancer and inflammation. The Gilead site in San Dimas, one of the three manufacturing sites owned by Gilead, is a 200,000 square foot facility. The San Dimas operation supports manufacturing, filling, packaging and labeling for a variety of products representing over 70% of Gilead’s products destined for the “Americas”. To support these operations, the engineering department at San Dimas, manages capital projects ranging from $3,000 to over $40 million using different management tools. Unfortunately, Gilead’s current capital management approaches, adapted from the chemical industry, do not address pharmaceutical industry specific requirements such as aseptic manufacturing. In addition, the lack of a uniform predefined business process may introduce capital management errors which can lead to extended project timing and increased costs. The Gilead TMP team was responsible for designing a ‘Business Process’ to enable the planning, prioritization, management, monitoring and evaluation of all capital projects at San Dimas. Additionally, the team was responsible for creating documentation including SOPs, guidelines and templates to support the capital process. To achieve these objectives, the team identified industry best practises for the capital project management process through literature review and input from key stakeholders. The team was able to establish a standard ‘Business Process’ tailored specifically for projects at San Dimas. 32 key documents for engineering and project management aspects were identified and developed to support the implementation of these processes. After launch of the process, Gilead, San Dimas should be able to adopt a streamlined approach to all its capital projects, leading to significant savings in terms of time and money. In the future this process may potentially be expanded to other sites at Gilead.