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PK and Immunogenicity Scientist Saint-Germain-Nuelles France,  

Posted on : 30 June 2017

Project Description

About Charles RiverCharles River Laboratories is one of the world s largest Contract Research Organisations with more than 8500 employees in 26 countries and is a market leader in the provision of product development services. At Charles River, we take a passionate approach to improving human and animal health.In Lyon, we are looking for a Senior Scientist, PK and ImmunogenicityResponsibilities: Develop PK, ADA, cell-based nAb assays in multiple species matrix and manage GLP and non-GLP method validation Manage outsourced generation of antibodies for use in PK, ADA, and nAb assays. Review study protocols, manage critical reagent lots, and monitor GLP sample testing. Attend internal and external project team meetings. Provide feedback on PK and immunogenicity assay timelines and budget. Realize quotes, evaluate technical feasibility and advise to Sponsors. Present work and effectively communicate progress at management and sponsors meetings. Provide answers to QA audits Provide scientific, technical and regulatory intelligence on PK, ADA, cell-based nAb assaysRequirements: Ph.D (or MS) in Biology or a related scientific discipline (PharmD, DMV) with >3 years industry experience in the bioanalytical field. (title commensurate with experience) Extensive, hands-on experience in development, transfer, and validation of PK, ADA and nAb assays at GLP CROs. Previous experience using MesoScaleDiscovery (MSD) platform and software analysis. Understanding of ADA and nAb assay distribution analysis, outlier identification, and cutpoint determination. Knowledge of relevant ICH and USP chapters, white papers, GLP requirements, and industry best practices. Demonstrated capability to work with team members to troubleshoot and identify solutions. Previous supervisory experience preferred. Prior experience working with Antibody Drug Conjugates or bispecific molecules is desirable. Ability to work effectively in a matrixed team environment. Ability to learn in a challenging environment. Fluent in English, French speaking as a nice to have


Saint Germain Nuelles France

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