Job summary
- Main area
- Biomedical Research
- Grade
- NHS AfC: Band 6
- Contract
- Permanent
- Hours
- Full time - 37.5 hours per week
- Job ref
- 196-RD495M
- Employer
- Guy's and St Thomas' NHS Foundation Trust
- Employer type
- NHS
- Site
- Guy's Hospital, CRF GMP Unit, 15th Floor Tower Wing
- Town
- London
- Salary
- £47,951 - £56,863 p.a. inc HCA (pro rata)
- Salary period
- Yearly
- Closing
- 29/06/2026 23:59
Employer heading
Advanced Therapy Production Scientist
NHS AfC: Band 6
Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.
Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup. St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.
Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.
Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.
In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.
We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.
Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’. Our adult community services achieved a rating of ‘outstanding’.
The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.
We have one of the most ambitious capital investment programmes anywhere in the NHS.
Job 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.
The post holder will work independently making informed decisions relating to manufacturing activities as delegated by the Head of Advanced Therapy Production to create procedures to ensure compliance with government legislation and trust requirements.
Main duties of the job
-
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
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Share responsibility in the upkeep of the unit including working with and around engineers to ensure planned maintenance as and when required
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Write and review instrument or process specific SOP’s and other documents
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Perform qualification duties on instruments and processes for manufacture of ATIMP’s.
- Provide assistance in production with academic collaborator Scientists
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Ensure that the products manufactured are labelled, documented and stored according to product specification and quality standards.
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Cell isolation using Magnetic sorting or fluorescent assorting within a GMP environment
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Closed system cell culture and activation
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Understanding of flow cytometry and proliferation methodologies
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Cell transduction using different viral vectors
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To work collaboratively with internal and external collaborators
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Scale-Up work within the GMP unit to optimise the procedures
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Perform process validation work such as Engineering Runs
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Perform equipment validation work as required for different clinical trials
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Maintain, operate, and clean the GMP Units 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.
Working for our organisation
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.
Organisational Values:
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.
The post holder will:
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 GTIntranet.
Detailed job description and main responsibilities
Management and Leadership responsibilities
- 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
Quality Responsibilities
- 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
Documentation Responsibilities:
- Using specialist knowledge, write SOPs relating to specific GMP unit and manufacturing operations.
- Using specialist knowledge, undertake the development and generation of product specific SOP’s and batch specific documentation.
- Using specialist knowledge, undertake the development and generation of Product Specification Files for manufacture.
- Using specialist knowledge, undertake the development and generation of master batch manufacturing records for manufacture
Information management responsibilities
- Actively interpret data and participate in writing up the results of the project for publication.
- Use specialist knowledge to archive and store appropriately and securely information in accordance with Data Integrity policies and procedures.
The post holder is required to follow Trust policies and procedures which are regularly updated including:
Confidentiality / Data Protection / Freedom of Information
Post holders must maintain the confidentiality of information about patients, staff and other health service business in accordance with the Data Protection Act of 1998. Post holders must not, without prior permission, disclose any information regarding patients or staff. If any member of staff has communicated any such information to an unauthorised person those staff will be liable to dismissal. Moreover, the Data Protection Act 1998 also renders an individual liable for prosecution in the event of unauthorised disclosure of information.
Following the Freedom of Information Act (FOI) 2005, post holders must apply the Trust’s FOI procedure if they receive a written request for information.
Equal Opportunities
Post holders must at all times fulfil their responsibilities with regard to the Trust’s Equal Opportunities Policy and equality laws.
Please review Job description document for full responsibilities.
Person specification
Qualifications
Essential criteria
- BSc in Immunology, Haematology or equivalent experience
Desirable criteria
- PhD and/or MSc in Immunology, Haematology or equivalent
Experience
Essential criteria
- ATMP manufacture experience (e.g. T cell/NK cell or other cell products)
- Cell culture of primary human cells (GMP or lab setting)
- Understanding of medicines regulation
Desirable criteria
- Experience of cell therapy product development e.g. Process Development
- Experience of working in a GxP environment
- Cell isolation (e.g. T cells or other cell populations) Cell transduction using viral or non-viral techniques
Skills
Essential criteria
- Ability to work independently
- Ability to work within a multidisciplinary and diverse team
- Meticulous attention to detail as per GMP expectations, Able to contemporaneously record and review data
Desirable criteria
- Knowledge of EU-GMP guidelines and standards e.g. Eudralex Volume 4
- Experience of independently planning process development or change experiments
Documents to download
Further details / informal visits contact
- Name
- Sandeep Kumar
- Job title
- Head of Advanced Therapy Production
- Email address
- [email protected]
- Telephone number
- 02071887188
- Additional information
Dr Sandeep Kumar
Head of Advanced Therapy Production
Advanced Therapy Manufacturing (GMP) Unit
Guy’s and St Thomas’ NHS Foundation Trust and King’s College London
Clinical Research Facility
15th Floor, Tower Wing
Great Maze Pond
SE1 9RT London
Phone: +44-2071887188 Ext: 52703
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