Process Engineer/Analytical Dev Sp II

1. Our position

• Job title: Analytical Development Specialist II
• Location: Geel
• Remote work: sporadically, up to 10% travel

2. About the job

Our Team:

The MSAT Scientist 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 Sanofi Geel biopharmaceutical manufacturing site. The Recombinant Mammalian DS platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within Sanofi biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing/Quality Control support. The function is responsible for tech transfer activities including fit-gap assessment, validation, dossier sections preparation, & PAI support to enable launch of new and LCM products. Our expansive portfolio covers multiple products, modalities and expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20+ new products in next 3-5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates, synthorins and nanobodies. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.

Main responsibilities:

• Develop, execute and/or transfer liquid-chromatography coupled to mass spectrometry (LC-MS) methods.
• Act as expert for LC-MS and analytical HPLC.
• Integrate characterization LC-MS data with process/product knowledge.
• End- to-end method responsibility, starting with method development up to method validation and transfer into a quality control organization.
• Experience with common analytical workflows (peptide mapping, release glycans) is a plus.
• Identification of improvements for existing methods to introduce new technology, increase method robustness, and reduce release cycle time.
• Investigational support for product and process, generation of scientific/technical study protocols and report. Impact assessment upon signification deviations in the analytical methods, production process and providing technical/scientific expertise.
• Support analytical activities for product characterization, transfer and process improvements for products in late development, next-generation, or commercial phase.

3. About you

• Experience:
  • You have a PhD or Master in Life Sciences or equivalent through relevant experience.
  • Prior hands-on experience with LC-MS is mandatory.
  • Experience with large molecule LC-MS data interpretation (at intact of peptide levels) is a plus.
  • You have a good fundamental understanding of chromatography methods and can rely on this knowledge to accelerate projects and support troubleshooting. Prior hands-on experience with liquid chromatography and troubleshooting is highly desired.
  • You have at least 3 years of relevant experience in method development, validation, and investigation testing/support in an analytical function. This experience can be acquired as company or academic experience.
  • You have a good understanding of GMP and the manufacturing and testing of biologics.

• Personality and character
  • You are willing to work in the laboratory (50-75% worktime in the laboratory is expected).
  • You have a strong sense of ownership and responsibility.
  • You have a quality-oriented mindset.
  • You are flexible and willing to adapt to changing priorities and willing to learn at a rapid pace. You are willing to support small scale studies, quality investigations and MSAT driven projects both in the lab and as part of a cross-function teams.
  • You have an analytical problem-solving mindset; you are accurate and have and eye for details.
  • You are familiar with various statistical and data trending techniques.
  • You are a strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites.
  • You feel comfortable speaking in public.
  • You like to work in a team and consider yourself a good team player.

• Languages:
  • Dutch
  • English, fluent in writing and speaking