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Текст:
Hirify AI/Оригинал
TL;DR
Principal Scientist - Small Molecule LC-MS/MS (Bioanalysis): Leading small-molecule LC-MS/MS method development and validation for oncology, rare disease, and clinical pharmacology studies with an accent on triple quadrupole platforms, extraction strategy, and chromatographic troubleshooting. Focus on scientific accountability for regulated studies, reviewing GxP documentation, mentoring scientists, and representing Laboratory Services with clients, auditors, and inspectors.
Location: Merthyr Tydfil, United Kingdom
Company
hirify.global is a full-service CRO providing clinical development solutions for small and mid-size drug developers, with expertise in clinical pharmacology, oncology, and rare diseases.
What you will do
Lead small-molecule LC-MS/MS method development and validation from extraction strategy through fully validated assays.
Troubleshoot instrument, extraction, chromatographic, and method issues as the team’s technical escalation point.
Own assigned studies, including data integrity, regulatory compliance, protocols, validation reports, SOPs, documentation, and final reporting.
Mentor scientists developing their LC-MS/MS technique.
Represent Laboratory Services with clients, auditors, and sponsors, and provide technical input to Business Development.
Requirements
Extensive hands-on LC-MS/MS experience using triple quadrupole platforms in a regulated laboratory environment under GCP, GLP, and/or GMP.
Proven experience leading small-molecule bioanalytical method development and validation.
Strong knowledge of protein precipitation, liquid-liquid extraction, solid-phase extraction, and chromatographic troubleshooting.
Working knowledge of current bioanalytical method validation guidance.
Ability to review and approve technical documentation to GxP standards.
Experience managing study timelines and priorities under deadline pressure.
Nice to have
MSc or PhD in a relevant scientific discipline.
CRO or clinical trial experience.
Familiarity with MHRA Phase I Accreditation requirements.
Six Sigma, Lean, or project management certification.
Experience supporting audits and regulatory inspections.
Mentoring or informal line management experience.
Culture & Benefits
Work alongside experts from multiple clinical development and laboratory disciplines.
Exposure to innovative medicines in rare disease, oncology, and clinical pharmacology.
Opportunity to contribute to studies addressing serious unmet medical needs.
Hands-on scientific ownership within a growing CRO.
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