Clinical NGS Consultant (Contract)
Are you a HCPC registered Clinical Scientist with deep expertise in NGS validation and ISO15189 accreditation?
This contract role offers a unique opportunity to shape the setup and compliance of a state-of-the-art molecular diagnostics lab focused on liquid biopsy.
THE COMPANY
This leading precision medicine company is redefining cancer diagnostics through liquid biopsy technologies. By capturing and analysing rare circulating tumour cells and ctDNA, their platform enables earlier, more targeted clinical interventions. With an FDA-cleared platform already in use, the organisation is now expanding into advanced molecular profiling, requiring immediate expert input on NGS validation, clinical assay deployment, and laboratory accreditation.
THE CONTRACT ROLE
As a Clinical NGS Consultant, you will play a central role in establishing and validating molecular profiling assays for clinical use. Your key focus will be the validation and regulatory readiness of NGS-based assays, ensuring alignment with ISO15189:2022 standards. You’ll advise on lab setup, lead validation efforts, and support the accreditation process.
KEY RESPONSIBILITIES
* Lead NGS assay validation for use in clinical service offerings (ctDNA, CTC DNA/RNA, methylation).
* Guide the clinical lab through ISO15189:2022 accreditation, working closely with internal teams and external bodies (e.g., UKAS, MHRA, HTA).
* Support the implementation of data analysis workflows and reporting structures for NGS within a LIMS environment.
* Provide oversight on quality, compliance, document control, and risk management related to molecular profiling.
* Advise on clinical workflow design, SOP development, and audit-readiness.
* Mentor internal staff and review technical documents and data packages for regulatory submissions.
ABOUT YOU
This contract role will suit you if you have:
* HCPC registration in a genomic discipline.
* Extensive hands-on experience with clinical NGS assay development and validation.
* Demonstrable knowledge of ISO15189 and interaction with accrediting bodies (UKAS, HTA, MHRA, CLIA).
* Competence in handling complex clinical and sequencing data, including statistical analysis.
* Strong oncology knowledge.
* A flexible, proactive approach to consultancy work and a keen eye for high-quality documentation and compliance detail.
This is a contract opportunity based in Guildford. Flexible engagement options available.
To express interest or request more details, email tyler@singulartalent.io.
Let’s talk about how your expertise can make a clinical impact.