Principal Scientist

TL;DR

Principal Scientist (Bioanalytical): Lead the development, validation, transfer, and application of ELISA and LC-MS/MS analytical methods for bioanalytical studies with an accent on compliance with GCP, GLP, and GMP standards. Focus on troubleshooting complex analytical issues, ensuring data integrity, scientific oversight, and continuous improvement of laboratory workflows.

Location: Office based in Merthyr Tydfil, United Kingdom

Company

Full-service CRO with expertise in clinical pharmacology, oncology, and rare diseases, providing tailored clinical development solutions for small and mid-size drug developers.

What you will do

• Lead analytical studies from client onboarding to final reporting, ensuring regulatory compliance and scientific integrity.
• Develop, optimize, validate, and transfer bioanalytical methods using ELISA and LC-MS/MS techniques.
• Provide technical oversight, data review, interpretation, and reporting to regulatory standards.
• Manage study planning, resources, timelines, quality, and costs while collaborating with stakeholders.
• Mentor scientific staff, drive workflow improvements, and act as technical escalation point.
• Contribute to business development, audits, and presentations at conferences.

Requirements

• Degree in relevant scientific discipline (advanced qualification desirable).
• Extensive experience with ELISA and/or LC-MS/MS in regulated lab environments (GCP/GCLP, GLP, GMP).
• Proven track record leading bioanalytical studies: method development, optimization, validation, transfer, analysis.
• Strong expertise in immunoassay/mass spectrometry: setup, maintenance, troubleshooting, performance optimization.
• Deep knowledge of bioanalytical validation, data integrity, GxP compliance, and regulatory reporting.
• Excellent organizational, communication, and project leadership skills; experience mentoring staff.

Nice to have

• MSc or PhD in relevant discipline.
• Experience in CRO/clinical trials, both ELISA and LC-MS/MS.
• Knowledge of MHRA Phase I Accreditation, process improvements, Lean/Six Sigma.
• Regulatory audit support, business development, line management experience.

Culture & Benefits

• Work alongside industry experts in innovative drugs for rare diseases and oncology.
• Collaborative laboratory environment focused on patient impact and continuous improvement.
• Permanent full-time role with opportunities for career growth in challenging therapeutic areas.