Independently conduct routine analytical testing, method qualification, and stability in a GMP environment in at least two areas: LC (PA, SEC, RP), CE (icIEF, CGE-SDS), OD, Immunoassays (ELISA), or ddPCR.
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.
Job details
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Estelle Kotelon
randstad operational
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Independently conduct routine analytical testing, method qualification, and stability in a GMP environment in at least two areas: LC (PA, SEC, RP), CE (icIEF, CGE-SDS), OD, Immunoassays (ELISA), or ddPCR.
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.
Qualification
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 departments.
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.
