Associate Director, Manufacturing Technical Services

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 looking for an Associate Director, Manufacturing Technical Services to join the team in Santa Monica, CA.

Primary Responsibilities:

• Direct activities of the Manufacturing Technical team responsible for Investigations, CAPA, Change Control, New Product and Technology Introductions from Process Development
• Investigate complex and operational process issues to provide effective and sustainable solutions
• Evaluate manufacturing capability (facility, equipment, process, systems, resources) for new product introduction
• Partner with Process Design Team and influence development of new processes
• Partner with MSAT on critical investigations
• Establish data analytics to serve as metrics and conducts critical review of data/trends
• Review/Approve technical reports and protocols in support of cGMP activities
• Responsible for evaluation and implementation of continuous improvement initiatives
• Hire, train, evaluate and review personnel

Qualifications:

• Bachelor of Science degree required, advanced science degree such as PhD or MBA is a plus
• 10+ years of GMP pharmaceutical manufacturing, technology transfer or process development experience
• Has proven prior people management experience.
• Demonstrates substantial knowledge of industry standard methodologies and trends.
• Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Clinical Manufacturing and Kite/Gilead in public forums.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates broad experience across areas such as manufacturing and understanding of cell therapy and aseptic operations.
• Cell culture or aseptic processing experience is a plus

#LI-JK1

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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