Process Engineer/ Analytical Dev Sp II
Sanofi
- Geel, Anvers
- CDI
- Temps-plein
- 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.
- Experience:
- You have a PhD or Master in Life Sciences or equivalent through relevant experience.
- Prior hands-on experience with LC-MS is highly desired.
- 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.
- You have a quality-oriented mindset.
- You are fluent in writing and speaking in English.
- 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 excellent 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 presenting/speaking in public.
- You like to work in a team and consider yourself a good teamplayer.
- Languages:
- Dutch
- English, fluent in writing and speaking