Functie

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 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 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 internal and external global sites in US and EU. We will be supporting launch of + new products in next - 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, Employering 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. Jouw profiel

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 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 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 Discipline Fysica Onderzoeksgegevens en –resultaten bestuderen en analyseren Discipline Aard- en milieuwetenschappen Discipline Chemie en materiaalkunde Discipline Mechanica, systemen en processen Noden van de industrie of instituten analyseren
Onderzoeksprestaties vastleggen Theoretische modellen ontwerpen (berekening, simulatie, modellering, ...) Wetenschappelijke onderwijsprogramma’s uitwerken
Cursussen afleveren Discipline Informatie- en communicatiewetenschappen Wetenschappelijk onderzoek en ontwikkelingen voorsen en verklaren Het verloop en de vooruitgang van wetenschappelijke experimenten en observaties leiden en controleren Onderzoekers, instituten, ondernemingen adviseren en wetenschappelijke steun bieden Wetenschappelijke, technologische, technische, reglementaire, … informatie opvolgen en actualiseren Een onderzoeksprogramma of –project uitwerken en coördineren Octrooien formaliseren en ontwikkelen Een dienst of onderzoekslaboratorium leiden Technologische of natuurlijke risico’s bestuderen (biologisch, chemisch, fysisch, …)
Preventieregels uitwerken Financiering en partnerschappen zoeken
Contracten opsen Berekeningen, metingen, experimenten en observaties uitvoeren
Resultaten controleren Discipline Medische wetenschappen Discipline Biowetenschappen Rapporten, publicaties en scripties opsen Methodes voor onderzoek en voor de gegevensverzameling en –analyse bepalen en ontwikkelen Het budget van een organisatie bepalen en opvolgen De strategie van het onderzoeksbeleid bepalen
Het wetenschappelijk onderzoekswerk evalueren Discipline Ruimtewetenschappen Discipline Wiskunde Aanbod Bedrijfsinfo

We, at , are there beside in need, as a health journey partner

+, employees, representing nationalities

countries where is present, providing healthcare solutions in countries

manufacturing sites in countries

Research and Development sites comprising medicines, clinical research and vaccines

We offer you Immediate permanent contract Full-time position in day shift (flexible working hour system) An attractive salary package with meal vouchers (worth €), a hospitalization insurance,.. Evaluations Educations Career opportunities in a growing organization where involvement, integrity, entrepreneurial spirit and collaboration are driving values

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