Das ist der Job
Strong expertise in GMP environment.
Das brauchst du
Qualifikationen 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.
Darum lohnt es sich
Familiarity with GMP, Quality Systems, and international guidelines (ICH, Pharmacopoeias). Team player with English communication skills; French is an asset.
Jobdescription 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.
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. 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.
