Your Role: As a Scientist 1 you will be responsible for the overall conduct of GLP or GMP studies as required. The Scientist 1 will provide scientific support to internal and external clients in relation to assays being conducted within the laboratory. Responsibilities include acting as Study Director or Responsible Scientist for routine GLP or GMP studies respectively, assisting in the performance of laboratory procedures, providing scientific support to laboratory staff performing routine procedures and external clients for whom the studies are being performed. The post holder is required to maintain study records, including deviation records, to meet regulatory standards. Key Responsibilities: Acts as a Study Director or Responsible Scientist for routine assays and as such hold’s responsibility for the overall conduct of GLP or GMP studies, respectively Works within the laboratory areas providing hands-on support, training, guidance and mentorship to laboratory based personnel to ensure routine client studies are completed on time to the appropriate scientific and regulatory standards Responds to audit observations through the Integrated Quality System Raises and progresses deviation and Corrective or Preventative Action (CAPA) records in a timely manner Writes and reviews regulatory documents including Standard Operating Procedures (SOPs), protocols, technical specifications and reports for routine procedures and assays Liaises with Commercial, Development Services, Programme Management and other Laboratory Operations to provide technical support for ongoing and upcoming projects, as required Participates in external and internal client conference calls, meetings and audits, including regulatory audits Proactively implements improvements to laboratory processes and procedures to improve efficiencies and reduce waste Responsible for ensuring all consumables and reagents relative to their studies are available in advance of study initiation Performs regular housekeeping and Health and Safety audits Ensures trending spreadsheets are completed in a timely manner for all studies in accordance with relevant SOP Writes and reviews assay risk assessments related to area of operational expertise Writes Genetically Modified Organism (GMO) risk assessments Actively maintains a clean, tidy and safe work environment Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures to ensure the welfare and safety of self and others Who you are: HND or higher qualification in a relevant scientific subject Extensive experience working within a scientific laboratory, ideally within a regulated environment. Knowledge & understanding of GLP / GMP regulations. Computer literacy and entry of data into databases Actively updates skills and knowledge in order to remain professionally competent and aware of developments within scientific discipline and our industry. Knowledge & understanding of Molecular Biology techniques (e.g DNA extraction, QPCR, DNA sequencing) is advantageous