Analytical Development Sciences
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Our client, a prominent biotechnology organization, is looking for a specialist to lead activities within their stability and clinical release laboratory. The role focuses on performing and overseeing release and stability testing for products ranging from early clinical phases to phase III. The position involves collaborating in a cross-functional environment to ensure compliance with quality standards and regulatory requirements.
- Perform daily laboratory activities focused on release and stability testing for clinical products.
- Analyze and verify analytical data within a LIMS system to ensure accuracy and compliance.
- Coordinate with other analysts to organize laboratory workflows for release and stability analyses.
- Manage deviations, incidents, and result validations according to GMP standards.
- Execute analytical techniques including HPLC/UHPLC and capillary electrophoresis (CGE, iCE) for protein analysis.
- Ensure all laboratory activities adhere to HSE rules and regulatory requirements for various development phases.
- Bachelor or Master’s degree in biochemistry or analytical chemistry.
- You have 5+ years of experience in the biotechnology industry.
- You bring expertise in analytical techniques including HPLC/UHPLC, CGE, and iCE applied to proteins.
- You possess a strong knowledge of GMP standards within a QC laboratory environment.
- You're proactive, meticulous, and able to work effectively in a multicultural team environment.
- You are fluent in English with the ability to read and interpret scientific documentation.
Nice to Have
- Experience with immunoassays and pharmacopeia testing.
- Knowledge of method transfers, co-validations, and specification settings.
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