Senior Scientist - Assay Verification Molecular Diagnostics

Origin Sciences; Cambridge; On-site; GBP 50,000 - 75,000; Full time

Benefits offered by this job

25 days leave

Pension

Competitive salary

Wellbeing program

Job summary

Origin Sciences, based at Granta Park, Cambridge, seeks an Assay Verification Scientist to lead verification across qPCR assays in a confidential molecular diagnostics programme. You will design, execute and report verification studies, ensuring robust evidence for transfer to internal or external labs and compliance with quality requirements.

Reporting to the Director of Innovation, you will collaborate with Quality, Regulatory, Clinical, Operations and suppliers to drive assay verification,

Qualifications

• MSc or PhD in molecular biology, biomedical science or related discipline.
• Advanced qPCR expertise with assay development, verification and validation.
• Experience across at least two major qPCR platforms and cross-platform transfer.

Responsibilities

• Plan, execute, analyse and report verification and validation studies (pre-analytics, nucleic-acid extraction, qPCR, controls).
• Develop and transfer qPCR assays across platforms; define criteria and evidence of performance.
• Evaluate LOD, precision, accuracy, reproducibility and robustness; manage variability.
• Define run validity and containment of contamination; escalate when data integrity is at risk.
• Produce clear protocols, reports, SOPs with traceability and CAPA.

Skills

qPCR expertise

Multi-platform qPCR

Data interpretation

Communication

Laboratory readiness

Education

MSc or PhD in molecular biology/biomedical sciences

Tools

QuantStudio

LightCycler

Bio-Rad CFX

LIMS

Job description

Our Company

The Origin Group Limited (TOGL (Holdings) Ltd) is the parent organisation and technical service provider to a focused portfolio of UK-based medical technology, research, and innovation companies. Organisations within the group include Origin Sciences, Ellele Health, and Biomii. Based in Granta Park, Cambridge, UK, the organisation has established, and managed, several clinical studies to collect and biobank a range of sample types, including mucus-based biospecimens using our proprietary medical device. The biobank provides a valuable source of clinical material that we use for research, method/technology development, and the creation of diagnostic assays.

Our Company

The Origin Group Limited (TOGL (Holdings) Ltd) is the parent organisation and technical service provider to a focused portfolio of UK-based medical technology, research, and innovation companies. Organisations within the group include Origin Sciences, Ellele Health, and Biomii. Based in Granta Park, Cambridge, UK, the organisation has established, and managed, several clinical studies to collect and biobank a range of sample types, including mucus-based biospecimens using our proprietary medical device. The biobank provides a valuable source of clinical material that we use for research, method/technology development, and the creation of diagnostic assays. Currently, our primary focuses are in the early detection of Colorectal Cancer (CRC) and pre-cancerous lesions as well as cancers of the gynaecological tract. Our motivation is to streamline diagnostic pathways, providing efficient screening, triage, treatment selection, and surveillance solutions with greater utility than existing methodologies, enabling healthcare systems to detect earlier, reduce waiting times, and minimise invasive procedures.

The Role

The Assay Verification Scientist will be the hands-on scientific lead for the laboratory supporting TOGL Group's confidential molecular diagnostics programme. The role will drive qPCR assay verification across multiple instrument platforms, laboratory readiness, controlled workflows and complex technical troubleshooting. The post holder will generate robust, traceable evidence that assays and workflows meet defined performance requirements and are suitable for transfer and future operation. Reporting to the Director of Innovation, the post holder will work closely with Quality, Regulatory, Clinical, Operations, Data, suppliers, external laboratories and development partners.

Requirements

• Assay verification: Plan, execute, analyse and report verification and supporting validation studies covering pre-analytics, nucleic-acid extraction, qPCR chemistry, controls, instruments, software and result generation
• Multi-platform qPCR: Develop, optimise, transfer and compare qPCR assays across instrument platforms; establish platform-specific settings, acceptance criteria and evidence of equivalent performance
• Performance studies: Evaluate limit of detection, precision and reproducibility, accuracy or agreement, analytical specificity, linearity or dynamic range, interference, robustness, stability and lot-, operator- and instrument-to-instrument variability
• qPCR interpretation and troubleshooting: Assess Ct/Cq behaviour, baselines and thresholds, amplification efficiency, standard curves, inhibition, control performance, non-specific amplification, multiplex interactions, drift, contamination and instrument or software issues
• Quality control: Define run-validity rules, control strategies, retest and discordance pathways, contamination controls and escalation criteria; reject or pause work where validity, safety or data integrity is at risk
• Laboratory readiness: Maintain equipment qualification, calibration and maintenance, reagent and reference-material controls, inventory, risk assessments, SOPs, training and competency records
• Technical documentation: Author clear protocols, reports, SOPs and technical summaries; maintain complete traceability and support deviations, CAPA, change control, design reviews and regulatory documentation
• Collaboration and transfer: Communicate scientific risks and recommendations to the Director of Innovation and to the broader team, support assay transfer to internal or external laboratories, and train or mentor laboratory personnel as the team develops

Essential Knowledge, Skills, and Experience

• Degree: MSc or PhD in molecular biology, biomedical science, microbiology, biochemistry, biotechnology, genetics or a closely related discipline
• Advanced qPCR expertise: Substantial hands-on experience developing, optimising, verifying and validating qPCR assays
• Multiple platforms: Advanced practical experience on at least two major qPCR instrument platforms, including transfer or comparison of assays between systems and management of platform-specific differences
• Multiplex assay knowledge: Strong understanding of multiplex qPCR, assay chemistry, primer and probe performance, channel selection, spectral overlap, optimisation and control design
• Data interpretation: Deep understanding of Ct/Cq values, amplification curves, baseline and threshold settings, efficiency, standard curves, dynamic range, inhibition, controls and acceptance criteria
• Molecular workflow: Strong practical experience with nucleic-acid extraction, specimen and matrix effects, pre-analytical variables and contamination molecular workflows
• Verification design: Experience defining acceptance criteria and evaluating analytical sensitivity, specificity, agreement, precision, robustness, interference and stability using scientifically sound study designs
• Regulated environment: Experience in IVD, clinical/molecular diagnostics, biotechnology or another quality-controlled laboratory setting, with working knowledge of SOPs, deviations, CAPA, change control, document control and data integrity
• Delivery and communication: Ability to take ownership of laboratory deliverables, analyse complex data, write clear technical documents and explain evidence, uncertainty and risk to different stakeholders

Desirable Knowledge, Skills, and Experience

• Direct experience with Thermo Fisher QuantStudio and Roche LightCycler platforms, particularly QuantStudio 5/7 and LightCycler 480 II; experience with Bio-Rad CFX, Qiagen Rotor-Gene or equivalent systems is also relevant
• Experience with automated extraction, liquid handling, digital PCR, LIMS
• Knowledge of ISO 13485, ISO 15189 and applicable UK or EU IVD requirements
• Experience in clinical molecular diagnostics, supporting regulatory submissions, or transferring assays between development and operational laboratories

About You

• You stay effective when priorities change frequently and are comfortable working with a degree of ambiguity
• You are self-motivated and can drive projects forward with minimal supervision, taking strong ownership and accountability for your work
• You thrive in a direct feedback culture: you give clear, timely and constructive feedback to colleagues, managers and reports, and you receive feedback in the same spirit
• You keep a level head under deadline pressure

Practical details

• Location: On-site at Granta Park, Great Abington, Cambridgeshire, CB21 6AD. This is a hands-on laboratory role and cannot be performed remotely
• Hours: Full-time. Occasional work outside standard hours may be required to meet project deadlines
• Right to work: You must have the right to work in the UK

Benefits

• 25 days annual leave (plus bank holidays)
• Pension contribution
• Competitive Salary
• Employee wellbeing initiatives