This post is based within the Advanced Therapies Facility (ATF) which houses both the Human Biomaterials Resource Centre (HBRC) and the GMP Manufacturing Facility (GMP-MF). The HBRC is an HTA licensed, ethically approved human sample biorepository providing sample procurement, processing, analytical and hosting services to biomedical research groups both in academia and industry. The GMP-MF is currently producing cell-based therapies for clinical trials. The ATF is a quality controlled environment highly regulated by both the MHRA and the HTA.
This position will support activity across the ATF and the post holder will be trained to cover both the HBRC and GMP-MF. Within the HBRC, the post holder will undertake the procurement and processing of biomaterials from patients in a wide range of disease settings for release or storage for biomedical research. In addition he/she will be delivering sample analytical and hosting services including samples collected from patients on clinical trials. They may be responsible for the oversight and delivery of all services associated with specific individual projects or collections. Within the GMP-MF, the post-holder would be supporting the production and quality teams in all aspects of production, quality assurance, quality control and facility maintenance. It is vital to have adequate staff capacity within the GMP-MF to enable manufacture for clinical trials to continue (according to strict protocols, timelines and quality standards compliant with the regulations) during periods of increased activity, annual leave or sickness.
The ATF has developed into a key facility helping to deliver translational research programmes which are central to the College research strategy. This specialist post is varied, requires a strong sense of initiative, and knowledge and experience of the applicable regulations. Good communication and interpersonal skills are essential to interact with academic, clinical and surgical staff, often with patients, engineers and visitors in order to correctly interpret and communicate problems in a timely manner. The post-holder must have the ability to work to strict timelines, but also flexibly, since priorities can alter quickly due to changes in patient scheduling. Some out of hours work may be required on occasions.
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