Principal Data Scientist
Role details
Job location
Tech stack
Job description
The Senior Scientist - Assay Development will lead the design, development, optimization, and validation of in vitro diagnostic assays for research and clinical applications. This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration with the other teams to ensure successful product development and its commercialization., * Develop custom assays for internal R&D and external clients, on platforms including NULISA, SIMOA and MSD.
- Design and execute experiments to develop assays and establish assay performance specifications (sensitivity, specificity, reproducibility) and validation (Hook effect, dilution linearity, parallelism, spike recovery).
- Optimize and troubleshoot assays to meet performance expectations.
- Participate in technical discussions and project meetings.
- Design and execution of verification and validation (V&V) studies, including all testing and documentation
- Perform data analysis and generate study reports
- Identify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvements
- Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies, Principal Scientist - Molecular Biology London, United Kingdom Employment Type: Full-time We are seeking an accomplished Principal Scientist in Molecular Biology to lead the development and expansion of our gene delivery and expression platforms, enabling the precise...
Requirements
You should have a strong understanding of the conceptual and practical application of the scientific framework for validation parameters, including but not limited to: standard curves and calibration, determination of Hook effect, dilution linearity, parallelism, and spike recovery. You should be confident with establishing assay performance, assay optimisation, intra- and inter-assay precision determination. Custom assay development on proteomic platforms including NULISA, SIMOA, and MSD, are especially valued.
You should preferably have a good understanding of the ICH guideline M10 on bioanalytical method validation, and strong experience with custom assay development on LBA formats including ELISA., * B.Sc., M.Sc, or Ph.D. in Biochemistry, Molecular Biology, Immunology, or related fields.
- 5+ years in custom assay development and validation.
- Hands-on experience with immunoassay formats (ELISA, chemiluminescence). Additional format including enzymatic assays, and molecular techniques (qPCR, sequencing) preferred but not essential.
- Knowledge and experience working within regulatory frameworks (e.g., FDA 21 CFR Part 820, ISO 13485, GCP, HTA) preferred but not essential.
- Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).
- Experience with Design of Experiment (DoE) preferential but not essential.
- Excellent documentation and communication skills.
Benefits & conditions
Up to £80k DoE plus package - London location - circa 3 days on site - Active SC and eDV eligibility required - Senior technical leadership role with strategic influence across multiple R&D programmes ABOUT THE CLIENT: Our client is a highly specialised technology...