USP Manufacturing Associate Scientist - Corsier Sur Vevey, Schweiz - Randstad

    Randstad
    Randstad Corsier Sur Vevey, Schweiz

    Gefunden in: beBee S2 CH - vor 2 Wochen

    Randstad background
    TEMPORARY
    Beschreibung

    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 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 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)