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Senior Process Engineer, Data Analytics

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

Kite is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment. As a Sr. Process Engineer I Grade 28 in Process Data Analytics group of global Manufacturing Sciences and Technology, you will provide analytical oversight for technology transfers, process validations and GMP manufacturing for Kite’s engineered autologous T cell therapy products.

Key Responsibilities:

  • Lead clinical and commercial cross-functional data analytics focused projects, investigations and task forces in support of process development, process characterization, process validation and raw materials organizations
  • Lead critical investigations, identify root causes and implement data-driven solution for manufacturing operations
  • Develop product related impact assessments to support deviations
  • Responsible for process monitoring and trending including authoring of process monitoring reports and manufacturing sections of annual product review
  • Write and review technical documentation (SOPs, protocols & reports)
  • Collaborate within a cross-functional development team to advance clinical and commercial manufacturing operations and related activities
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues

Requirements:

  • MS Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+ years of experience
  • BS with 7+ years of experience
  • HS Diploma with 11+ years of experience

Preferred Qualifications:

  • Life sciences or biologics experience in MSAT or technical services, technology transfer or process development experience
  • Working knowledge of statistical trending methodologies and reporting
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Demonstrated scientific and engineering expertise and/or principles
  • Cell culture, cell therapy and/or aseptic processing experience
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability
  • Experience in statistical analysis using JMP or Minitab
  • Proven track record of leading and managing cross functional teams
  • Knowledge of data management tools and statistical process controls