USP Manufacturing Associate Scientist

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Your role:

Within the Drug Substance Development (DSD) - Manufacturing department, we are looking for a "USP MFG Associate Scientist" 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 productFunctie-eisen
  

  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 at least 5 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)Inès d´Aubigny

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