Senior Manufacturing Specialist

Kite, a Gilead Company, is a 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. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.

Team:

Kite is establishing a technical services team dedicated to starting up and supporting operations of a viral vector plant. The team is on a rapid growth trajectory. This group will work on New Product Introduction (NPI), deviation investigation structure and ownership, CAPA implementation, and electronic batch record (EBR) implementation by bringing in multifunctional industry experience.

Responsibilities (including but are not limited to):

• Lead Tech Transfer of Kite's Pipeline products into Clinical/Commercial Manufacturing from Process Development representing manufacturing

• Support Tech Transfer for other stages of product lifecycle, such as Research or commercial manufacturing

• Lead project planning and utilize project management methodologies

• Use experience to provide resolution for technical challenges that may be encountered during Tech Transfer

• Lead cross-functional Tech Transfer teams, track project status, provide routine updates to leadership and perform risk identification and mitigation

• As part of Tech Transfer some travel may be required

• Implement Operational Excellence, Continuous Improvement and Lean manufacturing as core practices

• Assists in transfer of new technology into manufacturing from Process Development

• Supports technical transfer of test methods

• Investigate complex process and operational deviations to provide effective and sustainable solutions

• Applies analytical skills to evaluate complex situations using multiple sources of information

• Assesses feasibility of new or improved processes and conducts critical review of data/trends

• Evaluates use of alternate Raw Materials

• Supports QC on technical problems

• Implements current GMP and all other regulatory specifications as required

• Establish regulatory and SOP requirements

• Anticipates and prevents potential issues with regulators

• Provides guidance and technical advice

• Escalates potential quality issues to management

Candidate Qualifications:

• Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals

• Thorough knowledge cell culture or cell therapy manufacturing technical support

• Cell culture and aseptic processing experience

• Experience in Project Management and Project Management Methodology

• Experience leading tech transfers

• Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing

• Excellent presentation and communication skills with ability to clearly communicate to leadership or regulatory representatives

• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development

• Must be able to function and contribute as part of a team and contribute to team based decisions

• Ability to think critically, analytically and have demonstrated troubleshooting and problem solving skills based on deductive reasoning

• Ability to function efficiently and independently in a dynamic environment

• Demonstrates excellent written skills (especially technical writing)

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

• Well-developed computer skills and fluent with Microsoft office applications

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

• Core Values: Has high integrity, is inclusive of diverse backgrounds, is a team player, strives for excellence, is accountable

Preferred Qualifications:

• Thorough knowledge viral vector manufacturing technical support

Specific education/experience duration requirements:

• Bachelor's science degree with 10+ years of experience or Master's of Science Degree with 8+ years experience in Cell Therapy, Biochemical Engineering, Chemical Engineering, Biomedical Engineering, or Biotechnology

#LI-HH1

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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