Your role:
As part of the Global Drug Substance Development department, you will join a team of motivated scientists dedicated to create and implement solutions to support the development and manufacturing of new biological therapeutics. Viral validation is a key part of the process development and validation activities to ensure patient safety. Viral clearance needs to be evaluated for two main objectives:
To support IND and BLA submissions (clinical and market applications of monoclonal antibodies (mAbs)To support investigational studies evaluating the effect of new resins or non-platform conditions on viral clearance during process development activitiesViral clearance studies are conducted at a separate laboratory which is equipped to carry out virological activities and separated from the production site to avoid contamination of CHO cells culture used for production by the viruses used in the viral clearance studies. For these reasons, viral clearance studies are tedious and extremely costly. Your mission will focus on the evaluation of an innovative immuno-qPCR kit (MockV MVM® and RVLP kit) using non-infectious viral-like particles to evaluate the viral clearance capacity of a DSP purification step, to support in-house investigational viral clearance studies. You will design and execute laboratory experiments in collaboration with development, innovation and analytical teams. You will be trained to be autonomous and will have the opportunity to present your work during various meetings.
Your profile:
Master/engineer student in Biotechnology or related fieldsHighly motivated and autonomousAbility to conceptualize, solve complex challenges and to communicate about your projectGreat team spiritPrevious experience in DSP is a plusGood written and oral knowledge in English, French is a plus