John Robinson
Manchester
Summary
Detail-oriented Development and Validation Scientist with expertise in regulated bioanalytical environments (GCP, GLP, GMP). Experienced in immunogenicity assay development and validation, regulatory compliance (FDA, EMA, ICH M10), and method optimisation. Skilled in technical reporting, client communication, and troubleshooting within tight project timelines. Committed to advancing quality assurance in pharmaceutical testing and development.
Overview
4
4
years of professional experience
Work History
Bioanalytical Scientist
Intertek Pharmaceutical Services
Manchester
09.2022 - Current
- Lead scientist on immunogenicity assay development and validation projects under GCP/GLP guidelines.
- Oversaw full assay lifecycle: from feasibility and method development through to regulatory-compliant validation.
- Created SOPs, validation plans, and technical documents ensuring compliance with FDA, EMA, and ICH M10 regulations.
- Conducted thorough technical reviews, ensured data integrity, and authored key validation reports.
- Led technical reviews and client discussions, interpreting results and advising on strategic decisions.
- Managed multiple concurrent studies, delivering accurate results within critical timelines.
- Operated as MSD system owner—managing calibration, troubleshooting, and system performance across studies.
- Provided expert support to junior staff through structured training and ongoing mentorship.
- Identified issues, analysed information, and implemented solutions to enhance project outcomes.
- Actively engaged in scientific presentations; selected speaker at the REID Young Scientist Programme.
- Worked closely with team members on project goals.
- Prepared a range of written communications, documents and reports.
- Demonstrated consistent hard work and dedication to achieve results and improve operations.
- Developed excellent working knowledge of industry trends and improvements in processes.
- Maintained clean, safe working environments to eliminate accident risks.
- Handled customer concerns and escalated major issues to supervisor.
Education
MSc - Molecular Pathology
University of Manchester
Manchester, MAN01-2021
BSc (Hons) - Medicinal & Biological Chemistry
Manchester Metropolitan University
Manchester, MAN01-2017
Skills
- Method Development & Validation
- FDA Compliance
- EMA Compliance
- ICH M10 Compliance
- GLP/GCP/GMP
- Quality Assurance
- Laboratory Safety
- Data integrity
- Report writing
- Scientific Reporting
- Technical documentation
- Data interpretation
- MSD/ELISA/Gyrolab/Luminex
- GraphPad/SoftMax Pro/Sciex/Labware
- Regulatory compliance
- Project Management
- Project management
- Risk assessment
- Mentorship
- Training
- Technical Presentations
- Client Communication
- Team collaboration
- Team leadership
- Communication skills
- Problem solving
- Deadline management
- Deadline management
Websites, Portfolios and Profiles
www.linkedin.com/in/john-robinson-6b5727170
Additional information
Qualified Laboratory Safety Officer, Experience in costing and timeline estimation for client quotes, Commercial awareness and cross-functional collaboration experience, References available upon request
Publications
Sustained long-term disease correction in a murine model of MPSII following stem cell gene therapy, Mol Ther Methods Clin Dev, https://doi.org/10.1016/j.omtm.2023.101127
Timeline
Bioanalytical Scientist
Intertek Pharmaceutical Services
09.2022 - Current
MSc - Molecular Pathology
University of Manchester
BSc (Hons) - Medicinal & Biological Chemistry
Manchester Metropolitan University