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Open nowPosted 5 days ago

MSAT Scientist Analytische Validatie Biopharma

EURES job mobility portal314,718 open roles

Where
Turnhout, Belgium
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Your applicationOpen nowMSAT Scientist Analytische Validatie BiopharmaEURES job mobility portal · Turnhout, Belgium

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  5. 34.1%30 days
This job: posted 5 days ago

The posting

Functie omschrijving

Als MSAT Validation Scientist speel je een belangrijke rol in de ontwikkeling, validatie en overdracht van analytische methodes voor biologische geneesmiddelen binnen een biopharmaceutische omgeving in Geel. In deze functie combineer je wetenschappelijke expertise, labo-activiteiten en data-analyse om robuuste processen en betrouwbare kwaliteitsresultaten te ondersteunen. Je werkt daarbij nauw samen met teams uit R&D, QC, MSAT en met externe partners.

Jouw verantwoordelijkheden

  • Aansturen van validatie- en transfertrajecten voor analytische methodes binnen biologics.
  • Opstellen van protocollen, rapporten en SOP's in lijn met geldende richtlijnen.
  • Uitvoeren van analytische studies volgens onder meer ICH, USP en Ph. Eur.
  • Interpreteren van resultaten en uitvoeren van statistische analyses, onder andere met R.
  • Onderzoeken van afwijkingen en uitvoeren van root cause analyses.
  • Praktisch uitvoeren en ondersteunen van testen zoals ELISA, qPCR en receptor binding assays.
  • Optreden als technisch aanspreekpunt voor toegewezen methodes en producten.
  • Samenwerken met QC en andere betrokken stakeholders om methodeperformantie en kwaliteit te borgen.

Je werkt zelfstandig, neemt eigenaarschap over je projecten en weet prioriteiten te stellen in een dynamische omgeving. Dankzij je analytische ingesteldheid en duidelijke communicatie schakel je vlot met verschillende stakeholders in een internationale context.

Hard skills

  • PhD in Life Sciences, Biochemie of Biotechnologie.
  • Minstens 2 tot 5 jaar relevante ervaring binnen biologics of biopharma.
  • Ervaring met ELISA, eiwitinteractie-methodes en spectroscopische technieken.
  • Kennis van cGMP en relevante richtlijnen zoals ICH, USP en Ph. Eur.
  • Ervaring met analytische documentatie, validatie en method transfer.
  • Vlotte kennis van Engels; kennis van Nederlands is een sterke meerwaarde.
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