The Medicines Evaluation Unit (MEU) is one of the UK’s leading contract research organisations specialising in clinical trials and advanced laboratory analysis. We are expanding our Bioanalytical Science team and are seeking a motivated Bioanalytical Scientist to lead the development, validation, and delivery of high-quality biomarker assays for clinical trials and academic research.
About the Role
We are seeking a highly skilled and motivated Bioanalytical Scientist to join our dynamic laboratory team. In this role, you will contribute to the development, validation, and performance of cutting-edge assays in support of clinical trials and academic research. You will play a key part in maintaining high scientific, regulatory, and operational standards, while supervising junior laboratory staff and ensuring our bioanalytical facilities run smoothly.
This is an exciting opportunity for an experienced scientist with a strong understanding of bioanalytical techniques, regulatory requirements, and Good Clinical Laboratory Practice (GCLP).
Key Responsibilities
Assay Development & Validation
- Lead and support development and validation of biomarker assays, including flow cytometry and plate-based immunoassays.
- Prepare, review, and quality-check assay feasibility documents, method development and validation plans, and associated reports.
- Design and review laboratory source documentation for feasibility, method development, and validation studies.
- Ensure validation samples, materials, and reagents are prepared ahead of project initiation.
- Perform and support experimental work according to approved plans, analysing data and clearly communicating findings.
- Troubleshoot laboratory issues and propose process improvements.
- Contribute to scientific publications and deliver presentations internally and externally.
Assay Performance for Clinical Trials & Research Studies
- Write, review, and quality-check analytical protocols, study documentation, and reports.
- Supervise, perform, and verify bioanalytical assays according to study protocols or reference manuals.
- Adapt to changing priorities and ensure timely completion of daily tasks.
- Maintain accurate sample handling, storage, and documentation.
- Analyse and QC data from clinical and research studies.
- Coordinate sample shipments and support central laboratory oversight, including kit provision and sample receipt.
- Contribute to scientific reporting and presentations as required.
Study Team Collaboration
- Provide technical support to study teams on study days and liaise with internal and external stakeholders.
- Support interactions with sponsoring companies for assay feasibility, method development, validation, and analytical plans.
- Train staff on laboratory equipment and provide scientific and technical guidance.
- Supervise Bioanalytical and Research Technicians.
Laboratory Management & GCLP Compliance
- Oversee daily laboratory operations, maintaining SOPs, training records, and high-quality standards aligned with GCLP.
- Participate in laboratory rotas and housekeeping responsibilities.
- Keep up to date with advances in laboratory technology.
- Support COSHH assessments and manage laboratory stock, equipment monitoring systems, and service/calibration schedules.
Compliance, Governance & Health and Safety
- Maintain a personal training record and adhere to EU/UK Clinical Trials legislation and ICH GCP.
- Comply with all company and laboratory SOPs.
- Follow all health and safety procedures, use appropriate PPE, and report any incidents or equipment issues.
- Work responsibly to maintain a safe and compliant laboratory environment.
About You
Essential Skills & Experience
- Strong knowledge of bioanalytical techniques and regulatory requirements (e.g., GCLP, ICH GCP).
- Demonstrated experience in assay development, validation, and troubleshooting.
- Ability to analyse, interpret, and communicate scientific data accurately.
- Excellent organisational skills with the ability to prioritise in a fast-paced environment.
- Experience supervising or mentoring laboratory staff.
- Strong attention to detail and commitment to quality.
Desirable
- Experience with clinical trial sample analysis.
- Flow cytometry experience.
- Familiarity with central laboratory operations.
- Experience delivering scientific presentations or contributing to publications.
Why Join Us?
- Opportunity to work on innovative clinical and academic research projects.
- Supportive and collaborative team environment.
- Professional development and training opportunities.
- Contribution to impactful research that advances human health.