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.
Our client is an established and expanding CRO that offer full-service clinical development solutions.
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 and coordinate analytical studies from client on-boarding to final reporting with accountability for the regulatory compliance and scientific integrity of the study.
- Process samples generated in a clinical study for routine assay procedures as described in Standard Operating Procedures (SOPs) and Working Instructions and perform or supervise the processing of samples using Analyst software, i.e. routine processing of analytical batches using LC-MS-MS techniques, including review of chromatographic data
- Document procedures undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA+ and produce or review/approve relevant documentation such as protocols, procedures, validation/study reports, SOP?s, CAPA?s, file notes.
- Ensure all relevant study documentation are delivered to the client and archived within expected timeframes.
- 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. MHRA GCP for labs, GLP or GMP)
- Experience in using and troubleshooting LC-MS-MS analytical systems as well as the ability to develop and validate analytical methods using LC-MS-MS.
- The ability to document laboratory information to a GXP standard and perform quality control processes.
An excellent package is available including private healthcare, company pension, and a days holiday on your birthday.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53726 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 53726
Website: CK Group
- Posted: 20th June 2022
- Expires: 18th July 2022