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DSP Manufacturing Expert (Officer)

DSP Manufacturing Expert (Officer)

Informatik / Telekommunikation
  • Dauerstelle - Vollzeit
  • Referenz : INT-036657
  • Teilen:

Einzelheiten

  • Region Neuchâtel
  • Art des Vertrags Dauerstelle - Vollzeit
  • Tätigkeitssektor Informatik / Telekommunikation

Einführung

For our client who strives for a holistic approach in oncology and autoimmune diseases located in La Chaux-de-Fonds, we are looking for an individual as

DSP Manufacturing Expert (Officer)

(Permanent employment, fulltime). The earliest start date is as soon as possible. 

Aufgabenbeschreibung

  • Ensure the successful production of BDS
  • Support /perform the order of raw materials for campaign and ensure the follow-up with the suppliers.
  • Assist in managing supplier's relationships, take part of manufacturer site visit / audit
  • Manage equipment implementation / replacement.
  • Key contact in communication / interaction with collaborators from other departments
  • Perform all production operations according cGMP rules.
  • Perform or support MFG team leaders to carry out all the actions related to MFG operations for the release of the batches in a timely manner.
  • Support all deviations / CAPAs raised during the production runs.
  • Assist the Site Engineer with the maintenance and qualification of DSP equipment.


Erforderliches Profil

  • Ensure the writing of manufacturing documentation based upon tech transfer package from MSAT/Tech Ops department.
  • Participate in relevant meetings linked to specific projects and follow up of the specific topics linked to MFG DSP activities.
  • Participate to the process improvement with MFG team to implement new equipment or enhance process/organization in place
  • Participate to the organization of the pre-campaign period. Writing of recipes for the automated systems as the chromatography skid and the TFF skid.
  • Manage drafting, review and finalization of all relevant documentation (SOP, LB, RMS, validation protocols/reports and all documentation needed for production i.e.: process description, batch records etc.
  • Ensure the follow up of environmental status of Manufacturing area.
  • Ensure an efficient link with warehouse, MSAT, Process Sciences and the quality groups (QA and QC).
  • Assist in the organization of regular meetings, drafting of minutes and timely follow up of actions.
  • BsC, License or Engineer in biotechnology.
  • At least 3-5 years of relevant industrial experience in DSP operations: chromatography system (affinity, ion exchange, etc…) with Akta system and also UFDF and filtration techniques.
  • Relevant industrial experience in DSP operations and antibody production using single-use technology under cGMP rules is a plus.
  • Ability to work and collaborate in a strong team spirit.
  • Demonstrated skills in organization, problem analysis/solving and proactivity.
  • Fluent in French and able to use English language (both written and oral)


Application process:

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.

Informationen

  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 22. November 2022
  • Berater-in Olivier Freuler