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ETL Datawarehouse
Preparation and analysis of urgent samples in rapid response lab.
Gap-analysis for compendial methods for leachables and extractables to verify conformity with European and US regulations towards ISO 17025 certification.
Responsible for multiple FTEs and ensuring quality and compliance for regulatory requirements and qualification of new methods.
Data review from manufactured commercial CAR-T batches and following up on CAPA, deviations, and OOS.
Analytical development and design of high through-put bioassays of viral vector assays for CAR-T and advanced therapies.
Help set up sample and optimize process after transfer of activities from Belgium to Switzerland.
Preparation and analysis of samples and preparation for tech transfer of all assays from Belgium to Switzerland.
Testing for presence of antibodies and determination of blood type.
Degree in Biomedical Laboratory Technology.