Analytical Op&QC Lab Technician (m/f/d) - 9 months

Jobdescription

Independently conduct routine analytical testing, method qualification, and stability in a GMP environment in icIEF and/or CGE-SDS)
Deliver high-quality data treatment and analytical reports in a digitally agile manner.
Interact with customers to discuss results or coordinate routine and validation activities.
Work autonomously on routine/non-routine activities requiring specialized technical expertise (e.g., stability).
Strong expertise in GMP environment; validate GMP methods including analysis and documentation (mandatory).
Actively seek, share, and re-apply knowledge in your field.
Recommend and lead analytical workflow improvements in a cross-functional setting.
Present and defend relevant topics during health authority inspections.
Ability to write GMP documentation: URS, protocols, reports, instructions, deviations, CAPA, CCP Actions.

Qualifikationen

CFC or Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology.
5+ years of experience in an analytical laboratory within a GMP environment.
Practical use of (G)LIMS. Knowledge of Empower, Trackwise, Veeva, or Falcon is a plus.
At ease with writing GMP analytical protocols, reports, and SOPs.
Strong knowledge of LC, MS, CE, OD, ELISA, and/or ddPCR (testing, troubleshooting, cleaning).
Knowledge of CMC NBE/ADC development (ADC is an asset).
Familiarity with GMP/Quality Systems and international guidelines (ICH, Pharmacopeias).
Perform routine and non-routine analysis.
Able to handle deviations, CAPAs, and lead QC investigations to support other dep
CFC or Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology.
5+ years of experience in an analytical laboratory within a GMP environment.
Practical use of (G)LIMS. Knowledge of Empower, Trackwise, Veeva, or Falcon is a plus.
At ease with writing GMP analytical protocols, reports, and SOPs.
Strong knowledge of LC, MS, CE, OD, ELISA, and/or ddPCR (testing, troubleshooting, cleaning)
Team player with good communication in English (French is an asset).
Curious, proactive in proposing solutions, and driving improvements.
Able to do on-call duties and work during weekends.
Previously involved in 6S organization and proactive on planning.