USP Manufacturing Associate Scientist/ Senior Technician

vor 4 Wochen

Corsier Sur Vevey, Schweiz Randstad Vollzeit

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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