Functie

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 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

End- to-end method responsibility, Employering with method development up to method validation and transfer into a quality control organization. Subject-Matter expert on analytical technology e.g. binding-affinity, bioassays, spectrometric assays, molecular technology, ELISA, PAT technology, HPLC or HPLC-MS. Experienced with automated method execution or digitalization 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 You have at least years of relevant experience in method development, validation, and investigation testing/support in an analytical function You have a good understanding of GMP and the manufacturing & testing of biologics you are fluent in English writing and speaking You have specific experience in analytics e.g. H(U)PLC, UPLC-MS, Binding- affinity assays, bioassays, spectrometric assays, molecular technology, ELISA, PAT technology, ... Experience with growing cells in bioreactors or purification processes is a plus You are experienced in protein characterization 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 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 like to work in a team and consider yourself a good teamplayer

Languages

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

Employer
+ ..