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
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.
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).