Clinical Method Development & Validations Lead

NorbrookNewry, Down

Main Activities/Tasks

Subject matter expert in method development and validation.
Provide expert guidance on wide range of analytical extraction techniques to accurately and reliably extract analytes of interest from various matrices e.g. protein precipitation, SPE, Liquid-Liquid techniques.
Provide expert guidance on optimisation of analytical system settings (e.g. HPLC, UPLC, LCMSMS) to deliver reliable chromatographic methods suitable to measure low levels of analytes in a range of matrices.
Provide expert guidance on LC column selection appropriate to reliably separate various analytes from sample components and matrix.
Daily supervision, technical and managerial guidance of the Method Development and validation team.
Provide expertise and training to deliver methods and validations to facilitate delivery of the New Product Development bioanalytical programme.
Plan, lead and manage all bioanalytical method development and validation within the clinical laboratory in line with GLP, protocols, SOPs, VICH and other relevant international guidance.
Lead troubleshooting and root cause analysis of new and existing bioanalytical methods.
Maintain laboratory compliance with GLP, SOPs, company standards and relevant guidance.
Assist with management and control of the laboratory consumable spend.
Produce robust validated bioanalytical methods and reports and provide to the internal customer within agreed timelines.
Write and approve Methods of Analysis for routine use within the laboratory.
Ensure bioanalytical methods are suitably transferred to the analytical group.
Assessment of method performance after validation to identify and implement continuous improvements within the department.
Support preparation of documentation and responses to regulatory submissions and queries.
Conduct thorough investigations on deviations and analytical failures to determine root cause and suitable CAPAs.
Proactively propose CAPAs, drive completion of actions and effectiveness checks to monitor and measure impact of change.
Oversee on time in full responses to QA audit reports.
Assist in the preparation, implementation and review of GLP SOPs and ensure adherence to same within the laboratory
Identify and implement continuous improvements within the department
Hold regular team and one to one meetings to mentor, lead and further engage and support staff and build team skills.

Essential Criteria:

A relevant Biochemistry, Biomedical or other applicable Science based degree.
At least 4 years lab experience in a GxP laboratory, 2 years consisting of management.
A minimum of 4 years’ experience working in a laboratory environment with HPLC, UPLC, LCMSMS and frequent use of a chromatography data management system.
Proven ability to successfully develop, optimise and validate analytical methods.
Proven ability to problem solve and troubleshoot complex problems with methods and equipment.
Highly motivated and able to demonstrate experience and knowledge of a range of analytical extraction techniques e.g. protein precipitation, SPE, Liquid-Liquid techniques.
Good knowledge of Regulatory Guidelines.
Excellent oral and written communication and time management skills.
Experience of preparing and reviewing validation protocols, SOMs & SOPs

Desirable Criteria:

Experienced in DOE approach to method development.
Experience in use of Minitab or equivalent.
Working knowledge of GLP laboratory requirements.
Empower & Mass Lynx Chromatography Data management system experience
GC experience
Experience in regulatory inspections and preparing regulatory responses.
Knowledge of Regulatory Guidelines applicable to the GLP Laboratories.

The closing date for applications is Thursday the 25th of June 2026

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