Job summary
- Main area
- Biomedical Research
- Grade
- NHS AfC: Band 6
- Contract
- Fixed term: 12 months
- Hours
- Full time - 37.5 hours per week
- Job ref
- 196-RD087
- 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
- £42,471 - £50,364 p.a. inc HCA (pro rata)
- Salary period
- Yearly
- Closing
- 13/05/2024 23:59
Employer heading
Advanced Therapy Quality Control 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 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.
Main duties of the job
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.
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 help us to define and develop our culture, what we do and how we do it. It is important that you understand and reflect these values throughout your employment with the Trust.
The post holder will:
|
· Put patients first · Take pride in what they do · Respect others · Strive to be the best · Act with integrity |
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
Professional / Clinical responsibilities
- Lead in the testing of clinical grade gene and cell therapy products as determined by the clinical need of participants on current clinical trials as delegated by the Head of Advanced Therapy Quality.
- To ensure that the products tested, documented and stored according to product specification and quality standards, and regulatory authorisations.
- Management and Leadership responsibilities
- Attend and lead in presenting research and specialist technical knowledge at: lab meetings, seminars and national or international meetings where deemed appropriate.
· Share with others research and specialist technical knowledge related to the organisation, running and maintenance of the GMP unit.
· Work independently to undertake specialist tests and make informed decisions relating to products manufactured in the GMP Unit.
· Work independently to undertake specialist Validation and Qualification for the GMP Unit and its Equipment as delegated by the Head of Advanced Therapy Quality.
Testing Responsibilities:
- Using specialist experience in cell manipulation and processing for clinical use develop testing methods involving: flow cytometry; proliferation methodologies; nucleic-acid techniques; standard phamacopoeial methods for sterility, endotoxin, and mycoplasma detection.
- To work collaboratively with internal and external customers to undertake assay validation work within the GMP Unit to optimise procedures under GMP conditions and provide data for application to the regulatory authorities.
- To work collaboratively with internal and external customers to collate test data within the GMP unit to finalise the analytical procedure under GMP conditions and provide data for application to the regulatory authorities.
- To test cellular therapies under GMP conditions for use in clinical trials or as directed by a commercial organisation as the named contracted manufacturer.
- Maintain, operate, and clean the GMP Unit’s Equipment and facilities in compliance with Unit’s defined procedures and standards.
- Qualify, process validate and re-validate equipment and GMP procedures successfully and on schedule according to the Unit’s Validation Master Plan.
- Monitor and control the GMP Quality Control environment to ensure that standards of cleanliness and hygiene are maintained.
- Ensure all waste generated is subject to appropriate management and disposal.
- Quality Assurance Responsibilities
- Where directed or delegated by the Head of Advanced Therapy Quality assist in Quality Assurance activities relating to allocated projects, including Product Quality Review, and statistical analysis of compiled results.
- Take on delegated responsibility for quality review of Batch Manufacturing Records and other production records in support of certification and release of gene and cell therapy products.
- Lead laboratory investigations relating to out of trend and out of specification results.
- Manage deviations appropriately using quality assurance tools such as planned deviations, change control systems and quality exception reporting and investigations.
Documentation Responsibilities:
- Using specialist knowledge, write SOPs relating to specific GMP Unit operations. These SOPs must comply with GMP and the Unit’s manufacturing licence. Issue documents through the Unit’s Q-Pulse document control systems.
- 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.
4.6 Information management responsibilities
- Play a major role in generating data and for the application to the regulatory authorities for Clinical Trial Authorisation.
- 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.
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
- Postgraduate or equivalent specialist experience of Tissue Culture, Flow Cytometry and Quantitative PCR
- Postgraduate or equivalent specialist experience in cell manipulation/processing for clinical use and/or working in a Clean room.
Desirable criteria
- Experience in cellular immunology techniques such as proliferation, LDA, HLA-peptide multimers, cytokine secretion and ELISPOT assays
- Experience in Good Manufacturing Practice
Skills
Essential criteria
- Ability to participate in the organisation of the laboratory
- Ability to develop novel QC assays and assess suitability
- Knowledge of: environmental monitoring, specialist GMP unit cleaning, maintenance, validation and qualification of specialist equipment
Desirable criteria
- Knowledge relating to the manufacture and quality control of somatic cellular and gene therapy products within a GMP environment
Employer certification / accreditation badges
Documents to download
Further details / informal visits contact
- Name
- Sakina Gooljar
- Job title
- Head of Advanced Therapy Quality
- Email address
- [email protected]
- Additional information
Sakina Gooljar
Head of Advanced Therapy Quality
0207 188 7188 ext 56097
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