Analytical Operations and QC Laboratory Senior Technicia - 9 month

Your key responsibilities in this role are:

• Conduct routine analytical testing, method qualification execution as well as stability in an independent manner on:
  • Liquid chromatography (PA, SEC, RP,...)
  • Capillary Electrophoresis (icIEF, CGE-SDS)
• Able to validate/qualify analytical methods (LC, CE especially, but knowledge of OD, LC-MS, ELISA can be an asset)

in GMP environment

• Deliver data treatment/elaboration and analytical reports of high quality in a digitally agile manner.
• Interact with customers when needed, with the aim of result discussion or coordination of routine and/or validation activities.
• Works autonomously for the execution of either routine or non-routine activities within established procedures and practices that require knowledge of technical concepts or specialized technical expertise, i.e stability.
• Strong expertise in GMP environment.
• Validate GMP methods including analysis and documentation. Method validation knowledge is mandatory.
• Actively seeks, shares and re-applies knowledge in own field of activities.
• Actively recommends and leads analytical workflow improvement initiatives in a cross functional setting.
• Presents and defends relevant topics during health authority inspections.
• Ability to write GMP documentation: URS, protocols, reports, working instructions, deviations, CAPA, CCP Actions.

Who you are:

• Bachelor's degree (or equivalent) in Chemistry, Pharmacy, Biology, or Biotechnology.
• 5+ years of experience in an analytical lab within a GMP environment for CFC; or 5+ years with a Master's degree.
• Practical use and comfortable application of (G)LIMS systems; Empower knowledge is a plus.
• Ability to write GMP analytical protocols/reports/SOPs.
• Knowledge of Trackwise / Veeva / Falcon is an asset.
• Strong knowledge in LC and/or MS and/or CE, and/or OD and/or ELISA and/or ddPCR; routine testing, troubleshooting, equipment cleaning.
• Knowledge of CMC NBE/ADC development; ADC knowledge is a strong asset.
• Familiarity with GMP, Quality Systems, and international guidelines (ICH, Pharmacopoeias).
• Team player with English communication skills; French is an asset.