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uality Assistance works on innovative medicinal products under development.
The projects are on the development, validation and/or application of bio-analytical methods for the study of large molecules in biological matrices by Ligand-Binding and Cell-Based Assays in the frame of preclinical and clinical Pharmacokinetic and Immunogenicity studies.
Working in a team involved in projects outsourced by our clients, as a Scientist, you will develop, validate and apply analytical methods, based on a protocol and according to GLP / GCLP rules.
You will also process data and write reports and associated supporting documents.
The analytical techniques used are Elisa, MSD, Luminex,…
Depending on your skills and ambitions, progression in the job is possible.
Education
Master / Engineer, specialisation Biology or Biochemistry.
Skills
Technical skills
Required
Good theoretical knowledge and practical experience in immunochemistry (Elisa, MSD, Luminex,..) applied to PK, Immunogenicity and Biomarkers studies.
General skills
Pluses
Good knowledge of the Pharmaceutical sector and the GLP / GCLP rules
Knowledge of biological medicinal products (mAbs, ADCs, proteins, recombinant peptides) and associated regulations (EMA and FDA).
Language skills
In addition to proficiency in French, good command of English.
A firts practical experience in pharmaceutical sector in development, validation and application of Ligand Binding Assays.