The Regulated & Applied Development team is responsible for the late-stage development, verification & validation (V&V), lifecycle management, and performance maintenance of sequencing platforms and applied end-to-end workflows developed under ISO 9001 & 13485.
As a Grade 5 Development Scientist, you will independently design, execute and interpret complex experimental programmes to support regulated platform and workflow development, verification, and lifecycle improvements. You will operate with a high degree of professional responsibility and discretion, acting as a technical lead within defined project areas. Where required, the role holder leads the design and execution of complex laboratory-based verification and development experiments, ensuring experimental robustness, data integrity, and regulatory compliance.
You will be accountable for delivery of defined workstreams or project components, contributing directly to departmental objectives and ensuring scientific robustness, regulatory compliance and operational excellence. The role holder exercises judgement in translating regulatory and quality requirements into practical project-level activities.
You may act as a subject matter expert (SME) in specific technical domains and provide guidance, technical review and informal mentoring to junior colleagues.
The role holder designs and oversees complex verification/experiments, drives risk management activities (including DFMEA, PRA, RMP), authors and reviews high-level regulatory documentation, and acts as a technical delegate or subject matter expert within cross-functional project teams.
Working with minimal supervision, the role holder owns defined project workstreams, influences cross-functional stakeholders (QA/RA/Production), and contributes directly to departmental objectives and regulated product releases.
The role includes coaching and developing junior team members, improving quality systems and embedding best practice in verification and documentation standards.
Key Responsibilities
Project & Technical Leadership
- Provide day-to-day technical leadership within project teams, including oversight of progress, resolution of blockers, and alignment of cross-functional stakeholders.
- Own defined project workstreams, ensuring delivery against short- and medium- term objectives aligned to departmental goals
- Act as technical delegate or SME within cross-functional project teams.
- Drive risk management activities including DFMEA, PRA, RMP, and related mitigation planning
- Identify technical risks and propose robust mitigation strategies
- Provide technical leadership during experimental/verification failures, deviations and non-conformance investigations.
Verification & Design Control
- Where applicable, design and oversee complex laboratory-based development and verification experiments.
- Author and review high-level design and development documentation (e.g. DDPs, MDDs, DVPs, VERRs, VREP, PRDs)
- Ensure traceability between design inputs, verification outputs, and risk documentation.
- Lead and facilitate cross-functional risk analysis sessions.
- Support progression through design transfer and product release activities.
- Contribute to performance claims through robust experimental design and defensible data interpretation.
Advanced Data Analysis & Problem Solving
- Apply advanced analytical skills to interpret complex datasets and draw defensible scientific conclusions
- Independently diagnose root causes of technical or process issues and implement corrective & preventative actions
- Support development of improved analysis methodologies and documentation templates where appropriate
Cross-Functional Influence
- Act as a primary technical point of contact for QA/RA and other stakeholders during verification and regulatory discussions.
- Represent RAD in cross-functional meetings and core project discussions.
- Build and maintain strong working relationship across adjacent departments.
Continuous Improvement & Compliance
- Contribute to development and refinement of local and global QMS processes.
- Ensure documentation and project execution comply with ISO 9001 & ISO 13485 requirements.
- Proactively identify and implement improvements to documentation standards, verification workflows, and operational processes.
Coaching & Capability Building
- Provide technical review and feedback on documentation and experimental plans produced by junior colleagues.
- Deliver training and guidance in verification processes, risk management, and QMS systems (e.g. MasterControl, Jama).
- Support delegation of workstreams and development of junior team members’ independence.
Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
Skills Required
- Experience in regulated platform development under ISO 9001 and ISO 13485
- Proven experience designing and executing complex laboratory-based verification and validation (V&V) experiments
- Experience authoring and reviewing design control and regulatory documentation (DDP, MDD, DVP, VERR, VREP, PRDs)
- Experience with risk management activities including DFMEA, PRA, and RMP
- Advanced data analysis skills and ability to interpret complex datasets to draw defensible conclusions
- Experience with sequencing platforms, ideally nanopore sequencing or related molecular biology/NGS technologies
- Experience with QMS / requirements tools such as MasterControl and Jama
- Proven ability to act as technical lead/SME, provide cross-functional influence, and mentor junior colleagues
- Knowledge of design transfer, product release activities, and regulatory compliance processes
Oxford Nanopore Technologies Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Oxford Nanopore Technologies and has not been reviewed or approved by Oxford Nanopore Technologies.
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Fair & Transparent Compensation — Pay is considered good to above average across many roles, with employer-provided ranges visible for several U.S. commercial and applications positions and company materials emphasizing market‑competitive base pay. Commercial and some senior technical posts, particularly in the U.S., are positioned as competitive and often paired with strong variable components.
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Equity Value & Accessibility — All‑employee share plans in the UK and a U.S. employee stock purchase plan indicate broad access to equity as part of total reward. Company communications highlight attractive bonus and share plans that add meaningful upside beyond base pay.
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Healthcare Strength — U.S. roles indicate strong health insurance and core protections, while official materials and country overviews reference private medical coverage and wellbeing support. These elements position the health package as a notable strength alongside cash compensation.
Oxford Nanopore Technologies Insights
What We Do
Our goal is to enable the analysis of anything, anywhere, by anyone. We have developed the world’s first and only nanopore DNA and RNA sequencing platform. It’s a new generation of sequencing technology — the only one to offer: scalability to portable or ultra-high throughput formats, real-time data delivery, and the ability to elucidate rich biological data. We are aiming to disrupt the way that biological analyses are currently performed, and open up new applications that have a profound, positive impact on society. Our devices offer real-time analysis, for rapid insights, in fully scalable formats — from pocket to population scale — and the technology is being used in more than 100 countries worldwide. Founded in 2005 as a spin-out from the University of Oxford, the company now employs more than 600 people from multiple disciplines including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
