Process Engineer/Analytical Dev Sp II

Job description

About the job

Our Team:

The Process Engineer/Analytical Dev Sp II (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:

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Lead a team responsible for executing chromatography methods. Ensure the appropriate planning and correct execution of the assays; in case of assay failure or investigations, support root cause analysis.

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End- to-end method responsibility, starting with method development up to method validation and transfer into a quality control organization.

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Expert on analytical HPLC (HPLC-UV, FLR, RID, CAD) or HPLC-MS.

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Experience with common analytical workflows (peptide mapping, release glycans) is a plus.

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Experience with automated method execution or digitalization is a plus.

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Identification of improvements for existing methods to introduce new technology, increase method robustness, and reduce release cycle time.

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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.

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Support analytical activities for product characterization, transfer and process improvements for products in late development, next-generation, or commercial phase.

About you

Experience :

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You have a PhD or Master in Life Sciences or equivalent through relevant experience.

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You have at least 3 years of relevant experience in method development, validation, and investigation testing/support in an analytical function

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You are experienced with people management or willing invest in developing these skills on a short notice. You care for the wellbeing and development of your team members.

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You have a good understanding of GMP and the manufacturing & testing of biologics.

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You have a quality-oriented mindset.

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You are fluent in writing and speaking in English.

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You have specific experience in analytics e.g. H(U)PLC, UPLC-MS. You have a good fundamental understanding of chromatography methods and can rely on this knowledge to accelerate support your team members. Prior hands-on experience with HPLC and troubleshooting is highly desired.

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You are experienced in protein characterization.

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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.

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You have an excellent analytical problem-solving mindset, you are accurate and have eye for details

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You are familiar with various statistical and data trending techniques.

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You are a strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites.

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You feel comfortable presenting/speaking in public.

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You like to work in a team and consider yourself a good teamplayer.

Languages :

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Dutch

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English, fluent in writing and speaking

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.