Audrey Manière

~ Development and optimization of ELISA assays (with MSD technology) aiming various goals such as replacing an existing radioimmunoassay or moving to a multiplex format.
~ Product characterization using the Agilent 2100 Bioanalyzer technology
(Contractor position through Manpower Professional)

~ Development and qualification of ELISA assays for in-process testing in order to support the optimization of fermentation and purification processes during the development phase of a new vaccine.
~ Managed in-house assay requests, including performing assays, communicating with scientists, scheduling myself and another analyst for assays, analyzing and releasing the results.
(Contractor position through Manpower Professional)

~ Developed and optimized ELISA assays (bridging, competitive and neutralizing) in order to detect potential immunogenicity of therapeutic antibodies for preclinical and clinical studies
~ Pre-validated and validated ELISA assays (assessed criteria's: precision, accuracy, drug interference, linearity, LOD/LLOQ for 4 parameters logistic curves)
~ Optimized colorimetric ELISA assays using DELFIA and MSD technologies
~ Designing and performing experiments, generating protocols, results and validation reports, presenting the results during regular platform meetings
~ Supporting implementation of GLP compliance of labs with main focus on plate-based methodology (creation of SOPs and templates, validation and qualification of equipment)
~ Supporting troubleshooting for ELISA-related problems in the platform, ordered lab equipment (incubators, scales, washers)
~ HSE coordinator in the platform (performing monthly internal safety audit, training new team members on safety programs)

Development and qualification of ELISA assays
~ Managing the implementation, optimization, and validation (specificity, accuracy, precision, LOD-LOQ) of these assays
~ Planning the experiments, analysing the results, generating the protocols, SOPs and results reports, and presenting the results
~ Optimizing these ELISA assays using electrochemiluminescence (Sector Imager technology from Meso-Scale Discovery)

Involved in the development, optimization and validation of different human ELISA assays:
~ Managed the development and the optimization of assays (design and realization of experiments, generation of protocols and corresponding reports, presentation of the results during platform meetings)
Worked in collaboration with other platforms to include Biacore and Luminex experiments in the development ELISA assays
~ Developed SoftMax Pro (4.7.1 Enterprise) templates for the data analysis and reviewing. Trained coworkers on SoftMax Pro
~ Helped managing the lab on a daily basis for several clinical studies in compliance with the FDA guidelines (planning of experiments, reviewing of data, training of new employees, technical troubleshooting, LIMS)
~ Worked on the automation of an ELISA assay

Supported clinical testing of a functional Cell-based Assay (cell culture, virus titration, LIMS)