Nadine Lambert, Email & Phone Number

Paris, Fr

Région De Paris, France

* Gestion d'un portefeuille client de fabricants de dispositifs médicaux de diagnostic in vitro au niveau international,* Evaluation de la Documentation Technique pour marquage CE conformément aux exigences de la Directive Européenne 98/79/CE, du règlement (UE) 2017/746 et des normes applicables* Audit Système qualité ISO 9001, ISO13485, CE (IVDD/IVDR)* Participation à des groupes de travail sur le réglement (UE) 2017/746 et les Diagnostics Compagnons * Veille scientifique et normative

-> Medicen (Pôle de compétitivité Paris-Région)In vitro Diagnostic CommissionParticipation in working groups for the emergence of collaborative projects, public / private: Biomarkers and psychiatry, Biomarkers and transplantation ...-> Integrated BioBank of Luxembourg (IBBL)Lecture : “What biomarkers validation means?”Reflection on the development of a biomarker validation program (evaluation of analytical and clinical performances, notion of clinical utility, regulatory framework ...)-> Paris Ouest Nanterre La Défense, University Project Management :* Project indicator of overall environmental quality of territories.* Participation in the UNESCO Chair project on Biodiversity.

Région De Paris, France

Project Management: in charge with a team of 17 people (managers and technicians), of an innovative project on the development of new multiplex assays, mandatory for blood transfusion (Hepatitis B & C, HIV, Syphilis, HTLV) :-> Prepare annual plans, propose budgets and investments (new projects, resources). Implementation of a monitoring tool of operating expenditures at the service-> Organize and manage teams and resources : animation of a team of project leaders and technicians (up to 17 people)-> Set up collaborations with external companies (French & American) for the evaluation of new technologies. For the first time, transposition of nano-spotting to the field of virology and qualification of blood donations -> Development of specific innovative control: deposit of patent.

Région De Paris, France

Team Management: 11 people (managers and technicians), in charge of clinical diagnostic reagents development in accordance with ISO 9001 and ISO 13485 for medical devices-> Development and launch of 4 hepatitis A diagnostic kits for US market (FDA-510K registration) and OUS market (CE marked 98/79/CE) -> Scientific and technological survey on the risks of transfusion-related to WNV and vCJD. Assays feasibility.-> Development of multiplex assays (Luminex technology) for Hepatitis A and B diagnosis: international patent granted.-> Coordinate a collaborative project (AP-HP, INSERM, Ariana, CNRS) Medicen labeled: development of new predictive markers of progression of hepatitis C (fibrosis) and response to treatment. 2 filing patents.

Région De Paris, France

Manage and coordinate new ELISA tests on automated systems or microplates, for the diagnosis of infectious diseases. Supervision of 4 technicians. -> Development of the first combined assay, detecting the hepatitis C infection earlier: Monolisa HCV Ag/Ab CE marked. Design of new innovative chemicals (international patent granted). Product N°1 (revenue) of « Blood Virus » product range-> Development of the new AccessTM Toxo IgM 2d generation (toxoplasmosis diagnosis) : specificity improvement -> Transfer products into manufacturing :Drafting manufacturing and control procedures (norms & specification), scale-up, pilot batches...

Région De Paris, France

Development at European level of new applications of enzyme immunoassays EnviroGardTM for the detection of pesticides (triazine chlormephos ...) and industrial contaminants (PCBs, PAHs ...) in water, soil and foods. Coordination and technical/scientific support to 7 European sales engineers.-> Technical problems solving at customer location within Europe (Hipp, Céreal, Bayer, Agence de l’eau…)-> Animation of 5 seminars (France Germany and UK) on Enzyme Immuno-Assay technics.

Région De Marseille, France

Study and selection of potato mutants with modified starch composition for the starch processing industry.-> In vitro culture of potato plant : protoplast culture. Ionization of protoplast in order to induce mutation-> Starch characterization -> Obtention of 2 plants meeting the expected characteristics used in starch processing industry.

Région De Paris, France

In charge of the design and development of enzyme immunoassay for the detection and quantitation of plant hormones (Auxine, cytokinine…) using monoclonal antibodies.-> Market survey and commercialization of 5 ELISA assays.

Côte D'Ivoire

Development of a process for the production of rotenoids (compounds with insecticidal activity) from plant cell culture in a fermenter. Optimize production using biotic and abiotic stresses.-> Selection of a cell line producing rotenone only. Production improved by a 5 factor after biotic stress.-> Training of Ivorian technicians: in vitro techniques and extraction and determination of natural plant substances.