Principal Scientist (Immunoassay)

CK Group are recruiting for a Principal Scientist to join a leading full-service CRO at their site based in South Wales on a permanent basis.
The Company:
Our client is an established and expanding CRO that offer full-service clinical development solutions.
Location:
This Principal Scientist role is located a commutable distance form Cardiff, Newport and surrounding areas.
Principal Scientist Role:
You will be a key part of the Laboratory Services team, leading Bioanalytical studies to analyse drugs, their metabolites, and other analytes primarily in biological fluids.
Your main duties will be to:
• Develop methods of analysis in order to deliver fully validated assays
• Coordinate analytical studies from client onboarding to final reporting with accountability for the regulatory compliance and scientific integrity of the study.
• Perform and supervise the processing of samples using Immunoassay techniques
• Document procedures undertaken and apply QC procedures to ensure their accuracy
• Produce and review/approve relevant documentation such as protocols, procedures, validation/study reports, SOP’s, CAPA’s, file notes.
• Provide technical advice to business development and participate in laboratory-related discussions with auditors, Sponsors and internal employees.
• Perform routine maintenance/calibration of instrumentation or equipment.
Your Background:
• Educated to degree level or above in life sciences, chemistry or a related file with experience of working in a regulated laboratory environment (e.g. GLP or GMP)
• Experience in using and troubleshooting ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA.
• The ability to document laboratory information to a GXP standard and perform quality control processes.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56600 in all correspondence.