Project Manager - In Vitro Toxicology

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.

ISO/IEC 17025 Technical Management:

• 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 organisation skills – ability to work to agree timelines; to prioritise own work and that of individuals working on the project, providing direction where required.
• Assess resource requirements, communicate requirements to management/resourcing, develops awareness of project cost vs gain.
• Initiates problem solving of adverse events during method development, validation, study and non-study work, encourages other to assist in providing solutions. Works with the Project Lead/Study Director to ensure that any issues/obstacles are documented correctly.
• Identifies process improvements and new/further method developments and shares with appropriate individual(s).
• Provides regular updates on projects delivery, highlights any potential issues which may affect timelines, quality and/or cost to Project Lead.

Associated Documentation:

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

Education/Qualifications:

• Degree in Biomedical/Forensics/Biological Sciences or equivalent is preferred but not essential.

Experience:

• Must have recognised project management and invitro 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 harmonization.