Associate Scientist - Expert

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.

• 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).

• 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.

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