Bioanalytical Scientist

Medicines Evaluation Unit Ltd; Manchester; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading research organization in the UK seeks a motivated Bioanalytical Scientist to lead assay development and validation for clinical trials and academic research. The role involves supervising laboratory operations and training staff while ensuring compliance with regulations. Candidates should possess strong bioanalytical technique knowledge and experience in clinical trial sample analysis. The position offers a supportive environment, competitive salary, and opportunities for professional growth.

Benefits

Competitive Salary & Benefits Package

29 days annual leave plus bank holidays

Company pension scheme

Free secure on-site parking

Qualifications

• Strong knowledge of bioanalytical techniques and regulatory requirements.
• Experience in assay development, validation, and troubleshooting.
• Ability to analyse and communicate scientific data accurately.
• Experience with clinical trial sample analysis.
• Familiarity with central laboratory operations.
• Experience delivering scientific presentations or contributing to publications.

Responsibilities

• Lead and support development and validation of biomarker assays.
• Prepare and review assay feasibility documents and validation plans.
• Supervise, perform, and verify bioanalytical assays.
• Maintain accurate sample handling, storage, and documentation.
• Train staff on laboratory equipment and provide technical guidance.

Skills

Bioanalytical techniques

Assay development and validation

Data analysis and interpretation

Flow cytometry

Supervision and mentoring

Attention to detail

Organizational skills

Job description

About the Role

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.

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.
• 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

• 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.
• 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.

MEU will offer you….

• Competitive Salary & Benefits Package
• A supportive, safety-focused working environment
• 29 days annual leave plus bank holidays
• Company pension scheme
• Free secure on-site parking