Assay Integration consists in all activities required to make in vitro diagnosis assays performing on automated laboratory analyzers. It typically applies to closed systems, where proprietary reagents are processed by fully automated instruments.In detail, the Team I am leading:- participates in the definition of requirements for both hardware and software, so to ensure proper assay processing and data reduction;- defines protocols, procedures, analytical methods and testing plans to develop, verify and validate the whole instrument or individual assemblies and consumables, also with the support of DOE techniques;- defines and distributes at Corporate level, by dedicated trainings and procedures, methods and standards in programming assay protocols;- validates assay performance from the analytical and clinical standpoint;- concurs in the definition of quality specifications and procedures for regular manufacturing of the validated product, so to ensure performance along product life cycle;- participates with active expertise in programs for reagents, hardware and software improvement.All activities are routinely carried out in a CE- and FDA-compliant environment.

Similar to following point.

In a CE- and FDA-compliant environment, in charge of:- ensuring compliance to expected quality standards of products of the ToRCH and Epstein Barr Virus panel;- definition of quality control methods and procedures;- participating in programs for improvement of performance and quality of reagents and assays- support Customer Care with analytical expertise.

In a CE- and FDA-compliant environment, in charge of:- development of latex immuno-agglutination assays for infectious serology markers (3 markers);- scale up to industrial scale of immuno-agglutination assays, both from the manufacturing and quality control standpoint;- development of CLIA assays for closed systems (2 markers).

In charge of:- participating in the development of ELISA assays for Tumor Markers; - leading the development of ELISA assays for the whole ToRCH panel (10 markers);