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Senior Engineer, Process Engineering

Product Sciences | Santa Monica, CA | Full Time

Job Description

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.

Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment.  As the Sr. Engineer you will provide process development and engineering support for technology transfer, process validation and GMP manufacturing for Kite’s engineered autologous T cell therapy products. Primary responsibility will be to engage in technology transfer activities between Kite facilities, including in Asia.  Additionally, you will draft and review protocols, production procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.  You will work with the Product Sciences team to design and scale-out cell therapy processes, and support process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio. 

Responsibilities include, but are not limited to:

·         Manage technology transfer and oversee GMP manufacturing operations

·         Act as technical expert to train and supervise process technicians

·         Write and review technical documentation (technology transfer protocols & reports, comparability protocols & reports, process validation reports, etc.)

·         Participate and report to a cross-functional development team to advance production activities

·         Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies

·         Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues

·         Design and execute process development studies to develop a thorough understanding of operating and performance parameters

·         Other duties as assigned

Requirements:

·         Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with at least 5 years of pharmaceutical manufacturing, technology transfer & process development experience required

·         Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices

·         Working knowledge of scientific and engineering principles

·         Experience in statistical analysis using JMP or Minitab

·         Practical experience in GMP operations

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

·         Ability to think critically, and demonstrated troubleshooting and problem solving skills

·         Excellent interpersonal, verbal and written communication skills

·         Ability to function efficiently and independently in a changing environment

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

·         Well-developed computer skills

·         Pharmaceutical products GMP manufacturing experience is a must

·         Cell culture or aseptic processing experience is a plus

·         Previous experience with cell therapy products is a plus

·         Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus

·         Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

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

·         Flexibility for international travel, including to Asia

Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10.  We are able to offer the opportunity to be part of the first 500 employees in this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.   Did we forget to mention the stock options?   To learn more about us, please visit our website at www.kitepharma.com

 

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