Responsible for the analytical development on biotech project in a cGMP environment
Identification of new methods and analytical equipment :bibliographic research.
Define,develop validate and execute the appopriate test methods to verify product performance.
Plan and implement analytical methods to assess the therapeutic proteins interactions with the medical devices: by SEC and a-FFF with MALS detection, by DLS and structural modification with UV, fluorescence and IR spectroscopy. Development of sub visible particules detection with HIAC and MFI equipments according to usp guidelines.
Train, educate and support lab operators, new comers and back up.
Developing technical skills and judgement, problem solving skills,understanding of design control product development processes.
Ability to write documentation in english.
Mes compétences :
Qualité
R&D
Chimie analytique
Industrie pharmaceutique
Pas de formation renseignée