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PK and Immunogenicity Scientist Saint-Germain-Nuelles France,  

Charles River (company)


Posted on : 30 June 2017

Project Description

About Us:
  • 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



Responsibilities: 
  •   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


Requirements: 
  •   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

Locations

Saint Germain Nuelles France

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