Your role:
Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a "USP MFG Associate Scientist/ (Sr) Technician " who will support the USP large-scale operations (GMP and pilot).
You will be part of a team of technicians, engineers and scientists specialized in the production of recombinant proteins produced from animal cells.
You will support the USP activities from an operational and a documentation point of view: cell amplification, bioreactor in fed-batch or perfusion mode and clarification.
You will address various topics such as equipment, process and automation issues.
You will:
Perform operational USP activities
Facilitate tech transfer and scaling-up
Be responsible for the analysis of data, be able to present it and interact with different entities: QC, QA or with the project managers
Carry out the documentation related to your function
Participate in maintaining the functionality of the laboratories/clean rooms
Support documentation activities related to your domain as well as compliance activities (deviations, CCP, investigations...)
Participate in the continuous improvement of the area and its activities by proposing and participating in the implementation of improvement projects
Participate in test activities during the qualification of process equipment in the context of corrective or improvement changes if necessary
Participate in the start-up of new equipment (FAT/SAT tests, qualification, validation) related to the launch of a new product
Qualifikationen
Who are you:
You have a technician diploma, Bachelor or technical diploma in biochemistry/biology (CFC, HES, BTS, IUT...), or an engineering degree in the field of biotechnology/biochemistry
You have 1-2 years' experience in USP, ideally in the field of pharmaceutical production
You have a good knowledge of USP process
You have a good knowledge of BPF, GLP and/or GMP
Your knowledge of IT tools (Pack Office, Trackwise/ SAP, MES, LIMS) is a plus
Training in Operational Excellence (LEAN, BELT) is a plus
You are able to work as part of a team and have good communication skills with all stakeholders (Managers, Unit managers, scientists and technicians) and stakeholders from other departments (Production, QC, QA...)
You speak English and French (written and reading comprehension a plus)
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