Clinical Method Development & Validations Lead

Job : CMDV
Job type: Permanent
Location: Newry
Closing date: Thursday 09 Jul :00
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.

• 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

• 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.