Project Manager - In Vitro Toxicology LabCorp Harrogate, United Kingdom

This role is to provide scientific and operational leadership across assay development, validation, and study delivery to achieve ISO 17025 compliance for designated methods. The role will be a project and technical manager and will ensure valid, reliable results, robust data integrity; and an effective management system aligned with ISO 17025 and applicable GxP regulations (e.g., GLP, GCP) to support accreditation and client confidence.

Responsibilities

• Serve as Technical Manager for assigned methods with overall responsibility for technical operations, competence, and method performance monitoring; define competence requirements, authorisations, and ongoing training.
• Maintain the laboratory's management system in alignment with ISO/IEC 17025 Clause 8 (documentation, document control, records, risk & opportunities, improvement, corrective action, internal audits, and management review).
• Oversee participation in proficiency testing/interlaboratory comparisons (as applicable), trending of quality control data, and timely investigation of out‑of‑trend/nonconforming results.
• Define, apply, and document decision rules when issuing pass/fail statements against specifications.

Project Management

• Demonstrates organisational skills – ability to work to agreed timelines; prioritise own work and that of individuals working on the project, providing direction where required.
• Assess resource requirements, communicate requirements to management/resourcing, develop awareness of project cost vs gain.
• Initiate problem‑solving of adverse events during method development, validation, study and non‑study work, encourage others to assist in providing solutions.
• Works with the Project Lead/Study Director to ensure that any issues/obstacles are documented correctly.
• Identify process improvements and new/further method developments and share with appropriate individual(s).
• Provide regular updates on project delivery, highlight any potential issues which may affect timelines, quality and/or cost to Project Lead.

Associated Documentation

• Review/write laboratory SOPs and lab sheets in line with process improvements for study‑related work.
• Prepare new SOPs and lab sheets in relation to new assay types/product lines.
• Prepare/assist with the development of training guides/records in relation to new assay types/product lines.
• Prepare reports prior to QA audit and dispatch to the client as audited draft within chosen scientific discipline (10%).
• Produce a summary report of any method development/validation process undertaken and completed.
• Address eQA comments regarding procedures, raw data, and reports.
• Assist Project Lead to prepare protocol and report templates for new product lines.
• Assist in the preparation of validation protocols for new study types and/or method developments.

Qualifications

• Degree in Biomedical/Forensics/Biological Sciences or equivalent is preferred but not essential.
• Recognised project management and in‑vitro toxicology experience.
• Technical competence of routine and specialised aerosol generation techniques across a wide range of industrial applications.
• Experience of cross‑site collaboration helping to drive harmonisation.