Sr. Manager, Process Engineering - Process Monitoring (MSAT)

Company: Kite Pharma
Location: El Segundo
Posted on: June 26, 2022

Job Description:

Job DescriptionEveryone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?Kite is seeking a highly motivated individual with biotechnology experience to work on process monitoring support for the manufacturing of innovative T cell therapies used for cancer treatment. As a Senior Manager for Manufacturing Sciences and Technology (MSAT), you will lead the process monitoring support team in commercial GMP manufacturing by driving new systems, statistical techniques, predictive and trending analysis that would provide oversight for GMP manufacturing for Kite's engineered autologous T cell therapy products.Responsibilities (include but are not limited to):

• Evaluate new technology and data systems for introduction into GMP manufacturing
  • Integrate data collection for data automation
  • Develop and improve data-based process performance monitoring systems
  • Set up systems that consolidate the data across the organization
  • Introduce/integrate predictive modeling or other techniques for a proactive approach
  • Build advanced process monitoring analytics based on multivariate analysis
  • Translate the MSAT needs to develop tools, techniques, and metrics, and dashboards for insights and data visualization
  • Lead the process support team as the process monitoring expertise for manufacturing site
    • Monitor the site manufacturing processes to ensure a state of control,
    • Apply statistical process controls, control charts, data trending as part of the process monitoring program
    • Inform cross functional teams in root-cause investigations for deviation resolution of complex problems
    • Perform process data-driven deviation resolution and improvement project
    • Collaborate with technical and operational stakeholders, write or review SOPs and other data collection related documents as needed
    • Ensure Data integrity
    • Lead continuous improvement initiatives with high complexity and impact to global manufacturing network, often impacting commercial license.
    • Lead deviation reduction initiatives based on collected CPV process data
    • Manage talented data analyst and data miners, including organizing and prioritizing department goals & objectives
      • Effectively motivate and mentor team members thereby enabling their career growth
      • Conduct technical and scientific trainingRequirements:
        • BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, or equivalent with 8+ years of experience or
        • MS in Biochemical Engineering, Chemical Engineering, Biotechnology, or equivalent with 6+ years of experience
        • Proficient with multivariate regression analyses, predictive modelingPreferred Qualifications:
          • Expert Knowledge of data management tools and statistical process controls
          • Experience in statistical analysis using JMP or Minitab
          • Working knowledge of scientific, engineering principles as well as data integrity
          • Exercise sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives
          • Knowledge of pharmaceutical manufacturing of biotechnology products and process development
          • Well versed in cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
          • Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
          • Experience working with or leading cross functional teams to obtain project deliverables
          • Working knowledge of scientific and engineering principles
          • Certified Quality Engineer, Six Sigma Green Belt is a plusDoes this sound like you? If so, please apply today!#LI-ML1#IND123

Keywords: Kite Pharma, Los Angeles , Sr. Manager, Process Engineering - Process Monitoring (MSAT), Executive , El Segundo, California