Requirements: English
Company: Arcadis
Region: Geel , Flanders
Department Description
Join our dynamic Analytical Science and Technology (AST) team at state-of-the-art Geel biopharmaceutical facility. As part of our global Manufacturing Science, Analytics and Technology (MSAT) organization, the AST team serves as the bridge between research and development, manufacturing, and quality control, providing crucial analytical support throughout the product lifecycle. We collaborate closely with upstream and downstream processing teams to solve complex analytical challenges, troubleshoot manufacturing issues, and implement continuous improvement initiatives.
Our team is responsible for developing, implementing, transferring, and optimizing critical analytical methods that ensure the quality, safety, and efficacy of diverse biopharmaceutical portfolio. Our expertise spans a wide range of analytical techniques, including cell-based bioassays, enzymatic assays, immunological methods, protein binding assays, and advanced spectroscopic techniques. We are at the forefront of analytical method innovation, constantly evaluating and implementing new technologies to enhance our capabilities.
Beyond laboratory work, we provide essential regulatory support through dossier preparation, inspection readiness, and responding to regulatory inquiries. Our team''s analytical expertise is vital for successful technology transfers, both internally between sites and externally with contract manufacturing organizations.
By joining our team, you''ll contribute to bringing 20+ innovative therapies to patients in the next 3-5 years while developing your expertise in a scientifically stimulating, collaborative environment at the leading edge of biopharmaceutical development.
Main Responsibilities
- Support analytical technology transfer activities between sites or from/to CROs
- Develop, improve, and validate analytical methods for existing and new production processes according to regulatory requirements.
- Conduct analytical testing on non-routine samples to support process development activities from our MSAT Downstream Processing (DSP) and Upstream Processing (USP) teams
- Perform characterization testing on biopharmaceutical products using various bioanalytical techniques
- Troubleshoot and optimize analytical methods to support our QC laboratories and CROs
- Identify and evaluate opportunities for implementing new analytical technologies
- Provide analytical expertise for regulatory dossier preparation, inspections, and responses to regulatory questions
- Write comprehensive, high-quality study protocols and reports for method validation, transfer, qualification, comparability, and bridging studies
- Present results and findings at team meetings and cross-functional forums
- Support knowledge transfer and training of analytical methods across the organization
- Maintain and communicate critical documentation and knowledge.
- Perform data trending and monitoring of analytical methods to ensure reliability and effectiveness.
- Conduct root cause investigations analytical deviations.
About You
Experience:
- You hold a PhD or Master''s degree in Life Sciences, Biochemistry, Biotechnology or equivalent through experience
- You have strong hands-on expertise with cell-based bioassays, enzymatic assays, and protein binding interaction methods
- You have knowledge of spectroscopic techniques (e.g., SoloVPE, CD, DLS)
- Experience with automated liquid handlers (e.g., Tecan, Hamilton, Andrew) is considered an added value.
- You have proven experience in analytical method transfer, qualification, and validation
- You have excellent analytical problem-solving mindset and can independently design experiments
- You can handle multiple projects simultaneously while maintaining attention to detail
- You are comfortable supporting both laboratory work and desk-based analysis
- You have strong technical writing skills for protocols, reports, and regulatory documentation
- You can critically analyse data, draw scientifically sound conclusions, and communicate them effectively
- You can perform statistical analysis and interpret method performance parameters
- You have an excellent knowledge of cGMP and can translate regulatory requirements into effective action plans