Data AnalystNetherlands - HoofddorpProcess/Product Development & OperationsRegular
Everyone 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 data analytics experience to work on statistical analysis, process monitoring, data collection and data verification for the manufacturing of innovative T cell therapies used for cancer treatment. As Data Analyst for Manufacturing Sciences and Technology (MSAT), you will ensure data is validated and accurate, for use in our continued process verification program to ensure process is under control. You will write and review technical documents for process monitoring, support investigation on deviations, and improvement projects. Perform data collection and data automation from batch records and from laboratory experiments that will support process development and process characterization. Deliver this by driving commercial GMP manufacturing statistical analysis techniques that would provide oversight for GMP manufacturing for Kite’s engineered autologous T cell therapy products.
- Ensure the cell therapy manufacturing processes are in a state of control, applying statistical process controls, control charts, data trending as part of the process monitoring program.
- Write and review technical documentation (process monitoring reports, investigation reports, annual product reviews, quality management reviews, ongoing process verification regulatory commitments).
- Perform data collection and verify data quality/accuracy based on electronic or paper sources, coordinating changes/corrections if required.
- Support investigations on trend deviations, performing product impact assessment and root-cause analysis.
- Support process improvement projects and digitalization initiatives (electronic batch records, laboratory systems, centralized databases, automated analysis, real-time process monitoring).
- Provide data analytics services for investigations, product quality impact assessments, root-cause analysis for major and critical deviations to maintain routine manufacturing operations.
- Perform data collection and analysis for laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements
- Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory
qualification level as needed.
• Undergraduate Degree in Engineering, Data Sciences, Computer Science, Biotechnology, Statistics or related discipline. Master's degree preferred
• 1-2 years’ experience in statistical data analysis, pharmaceutical manufacturing or process engineering experience required
• Mastery of scientific and engineering principles
• Strong attention to detail
• Ability to function efficiently and independently in a changing environment
• Experience with data management and report preparation
• Excellent interpersonal, verbal and written communication skills
• Curiosity about the problem domain and an analytical approach
• Strong sense of ownership and growth mindset
• Well-developed computer skills
• 1-2 years’ experience in statistical data analysis, pharmaceutical manufacturing or process engineering experience
• Fluency in Excel advanced functions is a must
• Experience in statistical analysis using JMP, Statistica or related software is preferable
• Experience in data visualization tools like Power BI, Spotfire or related software is preferable
• Knowledge of data management tools and statistical process controls is preferable
• Pharmaceutical products GMP manufacturing experience is a plus
• Previous experience with cell therapy products is a plus