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(Senior) Data Science Analyst, MSAT

Netherlands - AmsterdamProcess/Product Development & OperationsRegular

Job Description

As a Data Science Analyst for Manufacturing Science and Technology (MSAT) you will provide statistical analysis, process performance evaluations and data science expertise for GMP manufacturing, technology transfers, projects, process validations for Kite’s engineered autologous T cell therapy products. Additionally, you will write technical reports, perform data collection and verification, elaborate control charts and statistical evaluations as part of the continued/ongoing process verification program and drive digitalization initiatives. You will work with the MSAT, Process Development, Manufacturing, IT and Quality teams to support data analysis for commercial manufacturing of cell therapies, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Key responsibilities:
• 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.

• Lead or support investigations on trend deviations, performing product impact assessment and root-cause analysis.

• Lead or 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.
• Perform multi-shift work as well as on call duties if required

• Other duties as assigned

Qualifications:
• Degree in Engineering, Data Sciences, Computer Sciences, Biotechnology or related discipline with at least 3 years of statistical data analysis, pharmaceutical manufacturing or process engineering experience required
• Statistical process control expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
• Mastery of scientific and engineering principles


Skills:
• Demonstrated knowledge of statistical data analysis and industry applications
• Ability to think critically, and demonstrated troubleshooting and problem solving skills
• Data-driven and detailed oriented mindset
• Ability to function efficiently and independently in a changing environment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Outstanding computer skills
 

Experience:
• 3+ years of statistical data analysis, pharmaceutical manufacturing or process engineering experience
• Experience in statistical analysis using JMP, Minitab or related software is a must

• Fluency in Excel advanced functions is a must

• Knowledge of data management tools and statistical process controls is a must

• Continued/ongoing process verification (CPV/OPV) experience is a plus

• Programming experience is a plus
• Pharmaceutical products GMP manufacturing experience is a plus
• Previous experience with cell therapy products is a plus

• Understands and employs principles and concepts of Lean Six Sigma to improve process capability