Posted: 4h ago
The role
Description 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.
