Advanced Therapy Production Scientist | Guy's and St Thomas' NHS Foundation Trust

Overview

The Advanced Therapy Good Manufacturing Practice (GMP) Unit is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15th floor of the tower. The GMP Unit is purpose built for the manufacture of Advanced Therapy Medicinal Products such as somatic cell therapies, gene therapies and tissue engineered products for early-phase clinical trials. It is used for both commercial and non-commercial clients as well as departments within GSTFT and KCL to manufacture products related to trials undertaken in the CRF and at trial sites across the UK.

The position on offer allows the applicant a unique opportunity to become involved in cutting edge translational research at the interface between science and clinical medicine. The position includes taking responsibility for developing and implementing independently:
Product Specification Files (PSFs), Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs) for Production activities of the GMP unit.

• Lead in the manufacturing of advanced therapy medicinal products
• Ensure that the unit is always well stocked
• Ensure receipt of raw materials and release as set out in policies
• Share responsibility in the upkeep of the unit including working with and around engineers to ensure planned maintenance as and when required
• Write and review instrument or process specific SOPs and other documents
• Perform qualification duties on instruments and processes for manufacture of ATIMPs
• Provide assistance in production with academic collaborator Scientists
• Ensure that the products manufactured are labelled, documented and stored according to product specification and quality standards
• Cell isolation using Magnetic sorting or fluorescent sorting within a GMP environment
• Closed system cell culture and activation
• Understanding of flow cytometry and proliferation methodologies
• Cell transduction using different viral vectors
• To work collaboratively with internal and external collaborators
• Scale-Up work within the GMP unit to optimise the procedures
• Perform process validation work such as Engineering Runs
• Perform equipment validation work as required for different clinical trials
• Maintain, operate, and clean the GMP Unit's Equipment and Unit
• Qualify, process validate and re-validate equipment and GMP procedures successfully
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained

Our values describe who we are as an organisation and help shape our Guy’s and St Thomas’ culture. They guide us in everything that we do and are central to how we deliver our strategy.

• Caring
  : we put patients first
• Ambitious
  : we innovate and strive for excellence
• Inclusive
  : we respect each other and work collaboratively

Our values and behaviours framework describes what it means for every one of us in the Trust to put our values into action. The framework can be found on our Trust careers pages and GT Intranet.

• Attend and lead in presenting research and specialist technical knowledge
• Share with others, research and specialist technical knowledge related to the organisation
• Work independently to undertake specialist tests and make informed decisions relating to production
• Work independently to undertake specialist Validation and Qualification for the GMP Unit and its Equipment

• Manage deviations appropriately using quality assurance tools such as planned deviations
• Manage change control systems using the unit’s Quality Management system
• Perform Risk Assessments as and when required
• Help QA close out outstanding activities related to production or other associated activities

• Using specialist knowledge, write SOPs relating to specific GMP unit and manufacturing operations
• Undertake the development and generation of product specific SOPs and batch specific documentation
• Undertake the development and generation of Product Specification Files for manufacture
• Undertake the development and generation of master batch manufacturing records for manufacture

• Actively interpret data…