Method Development & Validation Lead - new job in Newry, UK

We are working with a world-leading veterinary pharmaceutical company that has recently invested heavily in a state-of-the-art research and development laboratory. They have a strong existing portfolio of products and a growing pipeline and are committed to pursuing excellence, innovation, and quality as a company.

You can build your skills reporting directly to the department manager with the support of the friendly team. You will provide guidance and technical expertise for developing new methods and validating them. It also offers the opportunity sharpen your abilities in people management developing your staff with the five-tier learning and development platform to ensure they grow professionally.

Method Development & Validation Lead.

Role Overview:

· Subject matter expert in method development and validation particularly from patient serum samples. · Lead the team in developing analytical extraction techniques extract analytes of interest from various matrices e.g. protein precipitation, SPE, Liquid-Liquid techniques. · Provide expert guidance on LC column selection appropriate to reliably separate various analytes from sample components and matrix. · 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 · Recruit analytical staff and provide training plans, competency assessments, and mentoring to facilitate staff development. · Identify and implement continuous improvements within the department. · Conduct thorough investigations on deviations and analytical failures to determine root cause and suitable CAPAs

Essential: · A relevant Biochemistry, Biomedical, Chemistry or other applicable Science based degree and relevant experience. · At least four years lab experience in a GxP laboratory, with two years supervising or managing others. · Excellent analytical technique. · Good knowledge of Regulatory Guidelines. · Experience of preparing and reviewing validation protocols, SOMs & SOPs

Desirable: · Experienced in DOE. · Experience in use of Minitab or similiar. · Empower Chromatography Data management system experience · Method Development on platforms for LCMS and/or GC. · Experience in regulatory inspections and preparing regulatory responses.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.