Advanced Therapy Quality Control Scientist

The Good Manufacturing Practice (GMP) Unit at Guy’s Hospital was formed to accelerate the translation of novel approaches to the prevention, diagnosis and therapy of major unmet diseases relevant to the NHS, and will ultimately contribute to the improvement of patient outcomes. Specialising in developing and manufacturing cell and gene therapies for use in early phase clinical trials, the GMP Unit is looking to appoint a Advanced Therapy Quality Scientist. The field of Advanced Therapy Medicinal Products is expanding rapidly; this post gives the prospective candidate the opportunity to expand their horizons and promote this field. If successfully appointed, you will have gained at least a first degree or equivalent, and will ideally be experienced in developing and / or performing quality control assays for cell or gene therapies. You will support in the quality control of Investigational Medicinal Products (IMP) for clinical trials. You will assist with developing and improving existing quality control methods for testing the purity, identity, functional and safety profile of cell and gene therapies manufactured by the unit. You will play a key role in the quality control of IMP as determined by the clinical needs of participants in current and future clinical trials. You will also assist customers to develop In-Process Quality Control assays. You will work as part of a team maintaining the GMP facilities and equipment in accordance with maintenance and validation programmes. The successful applicant will operate within and contribute to a GMP Pharmaceutical Quality System including change control, preventive actions, deviation management and document control. Excellent interpersonal and communication skills are essential, as is the ability to work autonomously and as part of a team within a multi-disciplinary environment. Guy’s & St Thomas’ NHS Foundation Trust (GSTFT) and King’s College London (KCL) have formed a centre that has a strong focus on translational research taking advances in basic medical research out of the laboratory and into the clinical setting, forming a key part of the Department of Health's new strategy for research and development in the NHS. The Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital. The GMP Unit is purpose built for the manufacture of somatic cell therapies, gene therapies and proteins for early-phase clinical trials. It is used by staff from different departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK. For further details / informal visits contact: Name: Sakina Gooljar Job title: Head of Advanced Therapy Quality Email address: s.gooljar@nhs.net Sakina Gooljar Head of Advanced Therapy Quality sakina.gooljar@gstt.nhs.uk 0207188 7188 ext 54880