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PK and Immunogenicity Scientist - France
Charles River (company)
Posted on : 30 June 2017
- Our company 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.
- We take a passionate approach to improving human and animal health.
- In Lyon, we are looking for a Senior Scientist, PK and Immunogenicity
- 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 assays
- 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