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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?To strengthen our Clinical Stability and Specifications (CSS) Team, based in our Biotech Sciences Department in Braine-l’Alleud (Belgium), we are looking to fill the position of: Scientist CSS(Project Representative)As a Scientist CSS you like to work in an environment where you can:- Manage one or more projects (molecules) from Development Phases I to III as CSS/Project Representative.
- Handle the release and stability studies/strategies and ensure the specification setting for our NBE (New Biological Entities) molecules in development until commercialization.
- Managing the project by handling multiple priorities, provide leadership, organize the activities in relation with the CSS activities (release, stability, specification, comparability, reference standard strategies).
- Preparing (or support the review) protocols/reports and any required documentation related to CSS activities.
- Provide support for analytical troubleshooting related to the project.
- Supporting regulatory submissions by providing in timely manner the key deliverables from CSS and supporting the requests from Health Authorities.
- Interacting with key stakeholders as CSS laboratory, scientists from Analytical Development Department, Commercial QC, RA, QA, etc.
- Master’s Degree in Analytical Sciences, Biochemistry or Analytical Chemistry.
- At least 6 to 8 years of experience in a similar role.
- Expertise in Project Management.
- Expertise in release, stability and specifications for NBE (including experience with statistical approaches used for data analyses).
- Expertise in analytical techniques such as: chromatography, electrophoresis, immunoassays and pharmacopeias techniques applied to proteins.
- Experience with working to GMP
- Expertise of regulatory requirements.
- Very good command in French and English.
- Being autonomous with a problem solving & pragmatic mindset.
- You know how to manage your priorities and the stress that can ensue.
- Team player, you evolve together in taking initiatives and carrying out projects.
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締切: 10-01-2026
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