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レベル: Mid-Senior level
ジョブタイプ: Full-time
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仕事内容
Make your mark for patients.We’re here because we want to build the future and transform patients’ lives for the better.At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?UCB is a leading global pharmaceutical company, dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the areas of Neuroscience, Immunology and Oncology. The organization employs some 9000 individuals across approximately 40 countries. UCB is a pharmaceutical company with a size which enables it to deliver a significant drug pipeline, whilst remaining agile and innovative. For our talented scientists there isplenty of scope to influence the pipeline and make a difference to patientsand greatpotential to influence the strategy and drive the science. UCB remains a great opportunity for the individual to get a breadth of experience of the drug pipeline from research through to the clinic, whilst working in a highly collaborative environment to learn, contribute and gain visibility in a scientific and cross functional setting.To strengthen our Translational Biomarkers and Bioanalysis (TBB) team, we are looking for a talented individual to fill the position of GT ADA Laboratory Scientist,based in Braine-l’Alleud, Belgium.The Translational Biomarkers and Bioanalysis (TBB) Department is positioned within the function of Development Sciences, a division which provides strategy and support to transition novel pharmacological assets, including biologics and gene therapy derived assets, from research into the clinic. TBB operate and collaborate closely across the organization to support bioanalysis and biomarker activities.As part of the growth of UCBs gene therapy portfolio, the Translational Biomarkers and Bioanalysis group is looking for a highly skilled, experienced and self-motivated lab-based scientist to contribute to validation and sample testing in support of immunogenicity assessment of gene therapy and large molecule assets. This scientist will focus on regulated immunogenicity assessments in support of both pre-clinical and clinical studies. The successful candidate will operate in a GLP/GCP compliant facility to support assets from regulated tox onwards.Candidates should have a strong scientific background, good written and verbal communication skills and be able to multi-task effectively, adapting to meet the demands of a fast-paced matrix-team environment.Main Accountabilities- You will employ your proven expertise to contribute to the implementation of regulated gene therapy bioanalytical activities focusing on immunogenicity assessment.
- You will be responsible for running validation, and sample testing experiments.
- You will be the regulated bioanalyst responsible for delivering needs for pre-clinical and clinical studies
- Work with key stakeholders to ensure prioritization and optimal deployment of technologies.
- Work with method development scientists for the successful transfer of assays.
- Ensure compliance with all health and safety regulations.
- Maintain an awareness of new / emerging techniques and tools relevant to the field to ensure the group remains state of the art.
- Represent and align with the objectives of Development Sciences internally and externally.
- Extensive and proven experience in running immunogenicity assays for a wide range of modalities with the ability to contribute to gene therapy applications to support our growing portfolio.
- Technical understanding and experience across a wide array of ligand binding assay platforms and techniques (e.g. ELISA (enzyme linked Immunosorbent assay), MSD (mesoscale discovery)).
- Have a quality mindset that in line with working in GLP/GCP compliant facility as a lab scientist.
- Has the scientific and technical experience to perform validation and sample testing activities of immunogenicity assays effectively and delivery to key deadlines.
- Demonstrated ability to analyze, interpret and represent critical data in line with study needs
- Ability to work in a dynamic innovative environment which stimulates scientific interactions with a range of stakeholders including bioanalytical strategy leads, non-clinical safety leads, Clinical pharmacologists, statisticians, and other colleagues as needed.
- English: fluent, both oral and written. French will be considered a plus
- Previous experience of working in pharmaceutical research and development or allied partners such as such as CROs (Contract Research Organization) environment support drug development in a GLP/GCP compliant context
- Broad experience supporting regulatory bioanalytical needs including PK for biologics using ligand binding techniques and/or assessment of gene therapy vectors using PCR or ddPCR techniques
- Understanding of regulatory standards and industry best practices for PK and Immunogenicity assays.
- Experience working within a quality management system that enables generation of quality data through interactions with and range of colleagues including but not limited to quality assurance colleagues.
- Experience in writing of SOPs to support regulated activities.
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締切: 31-12-2025
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