Our client combines the therapeutic potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for large disease areas of high unmet medical need.
Founded last year, and based in Amsterdam, our client is a fully integrated gene therapy company focused on the development of innovative therapeutics.
With R&D and manufacturing facilities in Amsterdam, our client develops proprietary & partnered programs based on its novel AAV-based antibody gene therapy platform. Product candidates are based on capsid technologies, which will enable the next generation of highly scalable manufacturing processes within our client’s own manufacturing facilities.
Tasks related to LIMS:
Create a companywide LIMS structure, including sample management, equipment registration, implementation of material databases and GMO registration.Coordinate the implementation of assay-specific templates in collaboration with the keyuser(s) of each department.Implementation of other lab systems, such as quality documents, equipment data, barcodes, printers and scanners.Set up a system for migration of offline documentation.Follow-up on different issues that arise when using the system and communicate with the colleagues and consultants.Training for all key- and endusers and writing of a SOP.
Tasks related to EDMS:
Take the lead in the selection of a document management system.Take the lead in the Data Integrity of VectorY data and the storage of Raw Data files.Migration from current quality system to the document management system.Training for all colleagues and writing of a SOP.