Executive Director, Global MSAT Head

The Global Manufacturing Science and Technology (MSAT) Head is responsible for leading a team of site MSAT leads and data analytics group. Reporting to the Senior Vice President of Process Development, The Head of Global MSAT is a key leadership role within Kite Pharma's Process Development and Technical Operations. The Manufacturing Science and Technology (MSAT) division provides technical and organizational leadership support of clinical and commercial manufacturing for internal and external cell therapy and vector manufacturing operations. The position will provide program leadership for pipeline and commercial products, liaison with Manufacturing, Quality Assurance, Regulatory, Clinical Development, Operation Teams and various project stakeholders to meet Product Development's and Technical Operations' goals. The ideal candidate must have experience in the area of cell therapy and/or biologics, GMP manufacturing and excellent understanding of regulations.

Responsibilities

• Build strong technical MSAT teams at manufacturing sites including Southern California. Maryland and the Netherlands.
• Provide technical support for network wide technical issues that impact manufacturing operations and performance of the manufacturing process
• Provide leadership for defining and developing the next generation of production technologies and capabilities
• Lead data analytics and implement network-wide Continuous Process Verification (CPV) program
• Working with Head of Tech Excellence, establish robust tech transfer and new technology implementation processes
• Provide leadership to execution of process validation and comparability campaigns
• Review and provide technical expertise to regulatory filings and health authority questions
• Effectively & efficiently communicate manufacturing process performance internally and externally.
• Ensure product supply is executed effectively against the S&OP and meets quality requirement
• Influence and/or develop broad-based programs and initiatives to meet Kite Technical Operations' vision and mission
• Collaborate with other Tech Ops executives to set strategy and shared objectives
• Focus on results through the leadership of the site leadership team

Qualifications

• PhD/MS in relevant Science or Engineering with minimum 15 years of industry experience. Cell therapy experience is a plus.
• Strong knowledge of GMP compliance, regulations and manufacturing operations
• Experience in cell culture, aseptic processing, use of single use system and automation technologies
• Demonstrated leadership experience in building strong performing teams and leading senior technical leaders
• Good understanding of tech transfer, process validation and comparability
• Self-motivated, excellent prioritization, problem-solving and investigation skills
• Ability to manage budget and resource management
• Work collaboratively with Site Manufacturing and Quality Heads
• Excellent 360-degree communication skills
• Experience in manufacturing facility construction and start-up
• Knowledge of QbD and/or Six Sigma is a plus
• The position requires potentially 20% travel

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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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