Expert Biologics Analytical Operations
Randstad
Basel, Basel-Stadt
vor 1 Tg.

Jobdescription

For our client, a pharmaceutical company in Basel area, we are looking for an Expert Biologics Analytical Operations Start : asap

Length : until 31.12.2022

Tasks :

  • Responsible for the successful delivery of work packages to support GMP testing of Biologics clinical drug substances (DS) and drug products (DP) for release / stability / validation / transfer
  • Author and / or review of technical source documents in accordance with project timelines for global submissions.
  • Review high-quality CMC documentation for HA submission.
  • Supporting the release and stability strategy, the method validation and method transfer activities for our products covering development activities.
  • Support the operational aspects of GMP testing of Biologics clinical drug substances (DS) and drug products (DP).
  • Manage your activities and provide required documentation according to agreed timelines and standards.
  • Requirements :

  • Education Minimum : Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent;
  • advanced degree desired.

  • Minimum 2 years of Quality Control experience in a GMP environment and / or pharmaceutical industry experience.
  • Sound technical and scientific knowledge of pharmaceutical development and analytical sciences.
  • Knowledge on health authority regulations.
  • Proven ability to critically evaluate data from a broad range of scientific disciplines.
  • Proficient in English (other languages are a plus).
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