MSAT Development Specialist

  • TG23888
  • Geel
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Jouw talent hunter is Tinne Goris

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The Analytical function within global Manufacturing Sciences, Analytics and Technology (MSAT) is responsible for method development and supports method validation, all part of the Analytical Life Cycle Management (ALCM), within Sanofi Biologics network. We deliver innovative, robust, and cost-effective next-generation analytical methods. We support the commercial manufacturing and the quality control departments through testing support, in-depth investigations, characterization testing, and comparability assessments. The function is responsible for analytical technology transfer activities. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugate, synthorins and nanobodies. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.
In the Analytical MSAT function, we have opportunities for an Analytical Development specialist who will have the following main responsibilities:
– Support designing/developing/improving/validating existing analytical methods in function of existing or new production processes
– Independently set up experiments and develop and carry out studies in either a chromatography-oriented or cell & Biochemistry-oriented teams
– Provide documentation through generation of scientific/technical study protocols and reports
– Maintain, adjust and communicate documentation and knowledge.
– Data trending and monitoring of ongoing methods, experiments and analyzes to ensure reliability, as well as have an accurate understanding of the effectiveness and efficiency of the methods

Profiel

– You obtained, preferably, a PhD in Life Sciences or are equivalent through experience
– You have a very good knowledge of English, both written and oral
– you are expert in either chromatographic analyses assays e.g. HPLC/UPLC, MS, ion-exchange or/and in binding, capillary electrophoresis, spectrophotometric, immunological assays
– You have excellent problem-solving skills and can handle multiple (practical) tasks at the same time
– You have good technical writing skills and are able to prepare protocols and reports
– You are accurate, result-oriented and able to critically analyze data and draw scientifically sound conclusions and formulate them correctly
– You have an excellent knowledge of cGMP and can convert legal requirements regarding analytical methods into effective action plans
– You are a team player and have good communication skills
– You are flexible, stress resistant, open to change & innovation and are used to working with deadline

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