Your role
Reporting to the "Analytical Operations & Quality Control Lab Manager" in the Global Analytical Development organization, this role represents an opportunity to significantly contribute to high‑tech GMP analytical laboratories in the BDC, by proactively designing/executing new workflows in a cross‑functional set up. You liaise with peer QA, QC and manufacturing colleagues and you allow smooth analyses execution as well as documentation management and troubleshooting eager to develop in a context of growth, simplification, and changes to ensure the delivery of our specialty innovator Biotech pipeline to patients.
Your key responsibilities in this role are:
* Conduct routine analytical testing and method qualification, including stability, independently in at least two areas: Liquid Chromatography, Capillary Electrophoresis, and MS‑based methods.
* Deliver high‑quality data treatment/elaboration and analytical reports in a digitally agile manner.
* Interact with customers as needed to discuss results or coordinate routine/validation activities.
* Work autonomously on routine or non‑routine activities within established procedures, applying specialized technical knowledge (e.g., stability).
* Demonstrate strong expertise in a GMP environment.
* Validate GMP methods including analysis and documentation; method validation knowledge is mandatory.
* Actively seek, share, and re‑apply knowledge within own field; lead analytical workflow improvement initiatives in a cross‑functional setting.
* Present and defend topics during health authority inspections; write GMP documentation (URS, protocols, reports, SOPs, deviations, CAPA, CCP actions).
Who you are:
* Degree: CFC or Master in Chemistry, Pharmacy, Biology, or Biotechnology; ≥5 years in a GMP analytical lab.
* Proficient with (L)LIMS; Empower and/or Waters Connect a plus.
* Comfortable writing GMP analytical protocols, reports, and SOPs.
* Strong knowledge of Liquid Chromatography and/or Mass Spectrometry (routine testing, troubleshooting, cleaning).
* Knowledge of CMC NBE/ADC development; ADC knowledge is a strong asset.
* Familiar with GMP/Quality Systems and international guidelines (ICH, Pharmacopeias).
* Capable of performing routine and non‑routine analyses; able to sort deviations, CAPA, and lead investigations for QC.
* Team player with solid English; French a plus; curious about new tools/tech; proactive in proposing solutions and driving improvements; on‑call duties; 6S experience; strong planning.
What we offer:
We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
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