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Arcadis

MSAT Scientist

Hybrid

Geel, Belgium

Full Time

14-01-2025

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Job Specifications

Description:

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 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 12 internal and external global sites in US and EU.

Main Responsibilities
Take full ownership of the planning, execution, reporting and reviewing of analytical spectrophometrical and biological activity assays (aPPT, chromogenic activity, enzyme kinetics).
End-to-end method responsibility, starting with method handover up to method validation and transfer into a quality control organization.
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.

Requirements:
master or PhD in Life Sciences or equivalent through relevant experience.
Prior hands-on experience with plate based methods, experience with software softmax Pro is a plus.
willing to work in the laboratory (75% worktime in the laboratory is expected).
good fundamental understanding of spectrophotometry and potency methods and can rely on this knowledge to accelerate projects and support troubleshooting.
good understanding of GMP and the manufacturing and testing of biologics.
quality-oriented mindset.
excellent analytical problem-solving mindset, you are accurate and have and eye for details.
familiar with various statistical and data trending techniques, experience with Parallel Line Analysis (PLA) is a plus.
strong communicator, who can connect, go into discussion, and find compromises with people in other departments or sites.
comfortable speaking in public

About the Company

Arcadis is the world’s leading company delivering sustainable design, engineering, digital and consultancy solutions for natural and built assets. We are more than 36,000 architects, data analysts, designers, engineers, project planners, water management and sustainability experts, all driven by our passion for improving quality of life. We exist to find solutions to today’s most pressing challenges, from the impact of climate change to increasing urbanization and digital transformation – all with the goal of improving qual... Know more

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