Scientist Bioanalysis
Over deze vacature
Scientist Bioanalysis ProQR Therapeutics Leiden, Netherlands The role:
As Scientist Bioanalysis, you will be responsible for developing and executing the bioanalytical strategy for measuring oligonucleotide concentrations and relevant biomarkers in preclinical and clinical samples. Your work will generate critical pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data that support dose selection, target engagement, safety assessments, and the advancement of ProQR's RNA editing therapies into and during clinical development.
You will oversee bioanalytical activities performed both internally and externally, ensuring high-quality data are delivered on time and in compliance with applicable regulatory standards. A key aspect of the role is managing Contract Research Organizations (CROs), coordinating assay development, validation, and sample analysis while maintaining oversight of quality, timelines, and budgets. Key responsibilities: - Contribute to the bioanalytical strategy for ProQR's Axiomer® pipeline. - Select and implement bioanalytical and biomarker technologies, leveraging both internal capabilities and external platforms (e.g., ligand-binding assays, LC-MS/MS-based platforms, and other methodologies). - Lead outsourced bioanalytical activities by selecting, managing, and partnering with vendors for method development, assay validation, and sample analysis. - Coordinate bioanalysis analysis of both preclinical and clinical study samples, ensuring timely delivery of high-quality data to development programs. - Critically evaluate assay performance and interpret bioanalytical, biomarker, and PK/PD datasets to support translational development and decision-making. Required qualifications: - Hands-on experience with bioanalytical and/or biomarker assay platforms development, and validation of method such as hybridization based HPLC and ligand-binding assays, ELISA, PCR, and LC-MS/MS or related technologies. Experience sup...
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