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Process Engineer, Process Sciences and Engineering

Product Sciences | Santa Monica, CA | Full Time

Job Description

Kite Pharma 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 a Process Engineer, you will provide process development and engineering support for process design and development, process characterization, and leading process improvements in GMP manufacturing. Primary responsibility will be to lead and execute lab studies to develop and characterize the manufacturing process.  Experiments will be performed to identify and define Critical Process Parameters and process ranges.  Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiment (DoE) , and provide technical support for engineering and process changes.  You will work with the Process Science & Engineering team to design and scale-out cell therapy processes, and support process characterization, as well as draft documentation for regulatory filings to advance Kite’s product portfolio. 

 

Responsibilities include, but are not limited to:

  • Lead and execute laboratory studies to support process design and development, characterization and process improvements
  • Perform hands on work in a cell culture lab
  • Write and review technical documentation
  • 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
  • Perform process analysis and trend process performance
  • Design and execute process development studies to develop a thorough understanding of operating and performance parameters
  • Act as technical expert to train and supervise process technicians
  • Perform risk assessments
  • Provide technical support for selection of raw materials and process materials
  • Other duties as assigned

 

Requirements:

  • Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
  • Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Be familiar with basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, calculation of reagent quantities
  • Working knowledge of scientific and engineering principles
  • Experience in statistical analysis using JMP or Minitab
  • Practical experience in GMP operations
  • Document work accurately using GDP
  • 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 and aseptic processing experience is a must
  • Process modelling and simulation experience is a plus
  • Previous experience with cell therapy products is a plus
  • Process validation experience in a cGMP environment is a plus
  • Process automation experience is a plus
  • Six Sigma Green Belt or Black Belt certification 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
  • The primary location of the position is Santa Monica, but may be required to travel, based on business priorities

Kite Pharma is an equal opportunity employer based in Santa Monica, CA. Kite Pharma offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.       
To learn more about us, please visit our website at www.kitepharma.com.

No phone calls please and no agencies or recruiters.