Senior Manager, Manufacturing (MES)

Kite, a Gilead Company, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a Senior Manager, MES to serve as Business Owner of the Manufacturing Execution System for Kite's manufacturing network. The successful person will have at least five to ten years of experience in the biotech industry and will have demonstrated competency in leading MES deployment, implementing complex electronic manufacturing batch records and integration of MES with related business systems.

The Senior Manager, Manufacturing (MES) will work with Kite's global Manufacturing site teams to deliver the below objectives

• Translate process requirements and MES system best practices into practical, usable electronic batch records
• Develop design requirements, functional specifications, and support computer system validation strategy
• Develop and deploy global standards for batch record design, integration with process/test equipment and other electronic business systems
• Interface with vendors (as part of a team) to define user requirements and ensure the system design meets business requirements
• Develop business processes to support MES systems, from inventory control to batch record review
• Lead cross-site, cross-functional (quality, IT, supply chain, manufacturing, process development) collaboration to implement MES
• Provide technical support to Manufacturing sites, as needed
• Support MES life cycle strategy and business processes for change management (Guiding the design of a batch record), (Interface with vendor (s)), (Work cross-functionally to design, validate and deploy)

We are looking for a Werum SME, in guiding the design of the batch record, interfacing with vendor (s), and working cross-functionally to design, validate and deploy.

Must sit in Santa Monica office.

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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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