MSAT Scientist Engineer

☞ Akkodis

Aussicht: 105

Update Tag: 03-11-2025

Ort: Geel Antwerp

Kategorie: Planung / Projekte Beratung / Kundenservice Produktion / Betrieb

Industrie: IT Services IT Consulting

Position: Associate

Jobtyp: Full-time

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Jobinhalt

Description:

The Analytical Project Lead is a member of the Analytical Science and Technology (AST) team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science, Analytics and Technology (MSAT) organization and is based in the biopharmaceutical manufacturing site. The Recombinant Mammalian DS platform function within global MSAT is the owner of Life Cycle Management (LCM) of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network.

  • Lead the transfer and or co-validation of analytical methods in contract lab organizations (CLO) in close collaboration with internal experts on the analytical technologies.
  • Act as primary contact for the CLO, gather information and data generated at the CLO’s and evaluate against available internal data for existing or new production processes.
  • Plan the analytical project(s) in your responsibility, identify risks and report progress & risks to the analytical team and governance bodies.
  • Maintain, adjust, and communicate documentation and knowledge.
  • Write and review transfer/co-validation protocols and reports.
  • Support dossier submission activities with regards to analytical aspects

Requirements

Experience:

  • Preferably PhD in Life Sciences or are equivalent through experience.
  • Expertise in method transfer and validation in a GMP and non-GMP environment in accordance with current industry practices.
  • Excellent analytical problem-solving mindset (escalate when needed) and can handle multiple tasks at the same time.
  • Good technical writing skills and able to prepare protocols and reports. Able to draw up realistic project plan for method transfer/validation.
  • Expertise in analytical technology (e.g. spectrophotometry, biological activity, potency binding ELISA, BIAcore, Octet, …) is a plus.
  • Ability to work accurately while maintaining a strong focus on results and exhibiting a quality-oriented mindset.
  • Ability to critically analyze data, draw scientifically sound conclusions, and formulate them correctly.
  • Excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans.
  • Team player and have good communication skills.
  • Flexibility, stress-resistant, open to change & innovation, and used to working within deadlines.
  • Willing to adapt to changing priorities and willing to learn at a rapid pace.
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Frist: 18-12-2025

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