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Hoofddorp, North Holland, Netherlands

Hoofddorp, North Holland, Netherlands

As a Data Science Analyst for Manufacturing Science and Technology (MSAT) I 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, I 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. I 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.

Hoofddorp, North Holland, Netherlands

• Provide front line technical support for manufacturing of cell therapy products• Ensure successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting equipment and process issues• Partner with Product Sciences Team • In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools and product impact assessments.• Issues and implements CAPAs to address root cause and ensure effectiveness• Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents• Trends key performance metrics• Participates in internal audit/inspections• Represents Manufacturing operations in Change Control, CAPA and Deviation meetings• Conducts technical training and guidance to the Cell Therapy Specialists

Zoetermeer

Designing and Implementing an Assessment Tool to verify Label Claim Compliancy of all recipes in the product portfolio. Reporting and improving Quality related dataCoordination and Improving the Change Control process (upgrading from a paper-based system to a digital system)Supporting Overall Quality Improvements

Leiden, The Netherlands

The PER.C6 project was responsible to deliver a qualified vaccine facility. As part of the operational readiness team I was responsible for the following:- strategy and procedures regarding the transport and segregation of materials, equipment, intermediates and product- setting up an internal management system for the supply of consumables, disposables and equipment

Leiden, The Netherlands

Leiden, Netherlands

The purpose of the Integrated Data Management system is to provide a platform to capture and process analytical data for discovery, development and commercial manufacturing of pharmaceuticals. As Site Lead I represented the Leiden site and was responsible for the following:- the accuracy of the data and the content of the delivered reports- introduce new reports/templates based on business priorities- introduce data warehouse to new users / training of users

Leiden

Troubleshooting and support activities at the upstream departments (Pre-culture, Fermentation and Medium preparation)

Working as a Fermentation Subject Matter Expert at BTO Center of Expertise Cell Culture.Experienced in introducing new procedures, technologies and material at production departments. Interested/responsible for developing Management tools, like Time sheets, Resource Tools, Activity and Objectives Overviews.Very interested in Process Excellence Methodology, especially in Lean Thinking and Visual Scheduling

Leiden, The Netherlands

Activities for the production of antibody productions at the fermentation department

Leiden, The Netherlands

Technician at Fermentation department, additional skils back up teamleader from aug 2000 till jan 2002

Leiden, The Netherlands

Process operator at Fermentation department (cell culture)

Delft, The Netherlands

Education record

Microbiology