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Director, Advanced Analytics, Material Sciences & Technology

United States - California - Santa Monica, United States – RemoteProcess/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 Director, Advanced Analytics for Manufacturing Sciences &  Technology (MSAT) you will provide advanced analytics support for process and product comparability, process design and analytical development for the GMP manufacturing of Kite’s engineered autologous T cell therapy and vector products. Additionally, you will provide technical oversight into data historian/management systems, databases and advanced analytical/predictive modeling. Day to day responsibilities will also include complex investigations, technical reports, technical assessments, rationales 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 Process Development, Manufacturing, and Quality teams to develop data systems to automate and to visualize process and product development data for cell therapy and viral vector production processes, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.

Key responsibilities:

  • Lead development of data systems to automate and to visualize process and product development data for cell therapy and viral vector production processes, including implementation to GMP manufacturing to enable advanced process and product monitoring
  • Lead development of procedures and methods to assess the quality of cell therapy and vector manufacturing processes including monitoring of diversity and heterogeneity of cell therapy products
  • Participate in evaluation and development of new technologies and data management/visualization tools for process and analytical automation and implementation into GMP manufacturing.
  • Work with internal customers, vendors and suppliers to define requirements and understand functional specifications and evaluate technologies to improve final product characterization
  • Work closely with process design and analytical development teams to assure process reliability and robustness in preparation for comparability and process validation
  • Write and review user documentation (protocols & reports for comparability, process and cell therapy manufacturing process validation testing)
  • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation
  • Participate and report to a cross-functional global development team to advance production activities
  • Other duties as assigned

Requirements:

  • PhD/PharmD degree in Biochemical Engineering, Biotechnology or Life Sciences with 8+ years of pharmaceutical manufacturing, process development or process validation experience; OR
  • MA/MS/MBA degree in Biochemical Engineering, Biotechnology or Life Sciences with 10+ years of pharmaceutical manufacturing, process development or process validation experience; OR
  • BA/BS degree in Biochemical Engineering, Biotechnology or Life Sciences with 12+ years of pharmaceutical manufacturing, process development or process validation experience; OR
  • HS Diploma with 16+ years of experience also considered

Additional Qualifications:

  • Extensive pharmaceutical manufacturing, operations, process development or process validation experience is preferred
  • Cell culture or aseptic processing experience
  • Previous experience with cell therapy and/or vector products is preferred
  • Experience in statistical analysis using JMP or Minitab and applying various statistical techniques (ie. multivariate analysis) to resolve complex investigations is required
  • Specific knowledge and expertise in CPV trending and utilizing data management tools and statistical process controls to develop and apply appropriate limit into various control strategies
  • Experience in advanced programming languages R, SQL or database development is a plus
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
  • Consistent track record of leading and running multi-functional teams with an emphasis on career developing for internal team and business processes for implementation
  • Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
  • Proven 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
  • Ambitious and willing to accept temporary responsibilities outside of initial job description
  • Well-developed computer skills