Biomarker Specialist

Hobson Prior are looking for a Biomarker Specialist to join a leading biopharmaceutical company who purely concentrate on neurology and immunology. This position will be on a permanent basis located in Slough.

Job Responsibilities:

• Dual role: Scientific Project Team-facing as well as technical/laboratory-facing elements.
• You will help define the technical biomarker assay performance assessment requirements by bridging immunoassay feasibility with the scientific question.
• You will employ your expertise for the development of complex biomarker assays for measuring analytes in biofluids and tissue samples exploring diverse approaches to ensure delivery of high-quality fit-for-purpose assays.
• Accountable to manage and resolve complex scientific/technical challenges with innovative solutions whilst ensuring effective stakeholder interactions.
• Using in-house developed or commercially available immunoassays to measure the levels of biomarkers and biologic drug candidates.
• Assessment of novel biomarkers to ensure right dose, right molecule and right patient population within future clinical trials.
• Where appropriate, characterize antibodies, conduct reagent evaluation and perform reagent qualification assays.
• Provide in-depth knowledge of assay development and troubleshoot technical challenges across multiple platforms.
• Provide the appropriate levels of assay quality to ensure fit-for-purpose use.
• Work within the Bioanalytical area to optimize experimental design, troubleshooting, sample analysis, data interpretation and report generation.

Key Skills:

• Demonstrated ability to multi-task effectively in a dynamic laboratory environment to project timelines with minimal supervision.
• Ability to communicate clearly to colleagues, able to discuss ideas, provide constructive challenge and useful feedback.

Requirements:

• BSc in a biological discipline.
• Proven track record of developing bespoke fit-for-purpose biomarker immunoassays from first principles for pre-clinical and clinical assessments.
• Experience with linking Biomarker Strategy to Assay Specifications.
• Wide-ranging, direct, recent expertise with development of ligand binding assays/immunoassays from starting principles in the laboratory; the ideal candidate would be willing to contribute on an ongoing basis in the laboratory.
• Proven experience in immunoassays across platforms including ELISA, MSD, ELLA, Gyros, Singulex, Simoa/Quanterix, other; ability to compare case-specific pros/cons across platforms.
• Prior experience with initiating/defining requirements for case-specific tool reagent generation for assay development.
• Proven experience of biomarker assay development with diverse types of tool reagents.
• Proven experience of biomarker assay development across diverse immunoassay formats.
• Proven experience of factors for consideration for selection of appropriate endogenous controls and appropriate endogenous QCs tailored for the specific biomarker assay type.
• Firm understanding of biomarker assay validation for clinical assessments in the Clinical Study Report and demonstrable knowledge of the latest regulatory standards, industry best practices, attendance at relevant biomarker conferences.
• Clear grasp of context of use (linking assay requirements to the usage of the data generated).
• Proven experience with identifying limitations/caveats of biomarker assays.
• Proven experience with setting LLOQ, MRD, validation tier and acceptance criteria.
• Experience working with Critical Reagents for clinical study support.
• An understanding of the impact of biological and assay variability for fit for purpose biomarker assay development and data interpretation and proven expertise in delivery.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.