Clinical Method Development & Validation Lead

Clinical Method Development & Validation Lead

We are supporting a GLP-regulated veterinary pharmaceutical company in their search for a Clinical Method Development & Validation Lead to head up their bioanalytical method development and validation team within the GLP Clinical Research section of R&D. This is a hands-on leadership role, combining technical subject-matter expertise with day-to-day management of a laboratory team.

The Role

As Clinical Method Development & Validation Lead, you will act as subject matter expert for the development and validation of accurate, robust bioanalytical methods, providing expert guidance on extraction techniques (including protein precipitation, SPE, and liquid-liquid extraction), chromatographic system optimisation (HPLC, UPLC, LC-MS/MS), and LC column selection. You'll plan, lead, and manage all bioanalytical method development and validation activity in line with GLP, VICH, and internal SOPs, lead troubleshooting and root cause analysis on new and existing methods, and ensure the quality, accuracy, and integrity of all data and documentation produced by the team. You will also manage staff day-to-day, including training, competency assessment, development planning, and mentoring, and support audit readiness, regulatory submissions, and continuous improvement across the department.

About You

• A relevant Biochemistry, Biomedical, or other applicable science-based degree
• At least 4 years' laboratory experience in a GxP environment, including 2 years in a management capacity
• At least 4 years' experience working with HPLC, UPLC, and LC-MS/MS, with frequent use of a chromatography data management system
• Proven ability to develop, optimise, and validate analytical methods
• Proven problem-solving and troubleshooting ability with complex method and equipment issues
• Demonstrated experience with analytical extraction techniques such as protein precipitation, SPE, and liquid-liquid extraction
• Good knowledge of relevant regulatory guidelines
• Excellent oral and written communication and time management skills, with the ability to work under pressure and manage multiple projects and deadlines
• Experience preparing and reviewing validation protocols, SOPs, and SOMs
• Competent in Microsoft Word, Excel, and PowerPoint

Desirable

• Experience with a Design of Experiments (DoE) approach to method development
• Experience using Minitab or an equivalent statistical package
• Working knowledge of GLP laboratory requirements
• Experience with Empower and/or MassLynx chromatography data management systems
• GC experience
• Experience with regulatory inspections and preparing regulatory responses