# Advanced Therapy Production Scientist > NHS job listing from Job Clerk for Guy's and St Thomas' NHS Foundation Trust. ## Canonical URLs - **HTML:** https://www.jobclerk.com/job/advanced-therapy-production-scientist/c5573f0a-7b12-435f-ba8b-548c655d23eb - **Markdown:** https://www.jobclerk.com/job/advanced-therapy-production-scientist/c5573f0a-7b12-435f-ba8b-548c655d23eb.md ## Summary - **Status:** Live - **Employer:** Guy's and St Thomas' NHS Foundation Trust - **Town:** London - **Region:** London - **Country:** England - **Profession:** Health science services - **Grade:** Band 6 - **Salary:** £47,951 - £56,863 p.a. inc HCA (pro rata) - **Contract type:** Permanent - **Employment type:** Full time - 37.5 hours per week - **Closing date:** 2026-06-29T23:59:00.000Z - **Posted:** 2026-06-15T00:03:02.375Z - **Source information URL:** https://www.healthjobsuk.com/job/UK/London/London/Guys_St_Thomas_NHS_Foundation_Trust/Biomedical_Research/Biomedical_Research-v8052216 - **Application URL:** https://apps.trac.jobs/job-advert/8052216?ShowJobAdvert=&feedid=9002 - **Employer website:** https://www.guysandstthomas.nhs.uk ## Job Content ### 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 - 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 SOP’s and other documents - Perform qualification duties on instruments and processes for manufacture of ATIMP’s. - 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 assorting 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 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. ### 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. ## Job Details 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. ## Job Description 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 SOP’s and other documents Perform qualification duties on instruments and processes for manufacture of ATIMP’s. 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 assorting 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 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. ## 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 ### Skills **Essential** - 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** - Knowledge of EU-GMP guidelines and standards e.g. Eudralex Volume 4 - Experience of independently planning process development or change experiments ### Experience **Essential** - 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** - 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 ### Qualifications **Essential** - BSc in Immunology, Haematology or equivalent experience **Desirable** - PhD and/or MSc in Immunology, Haematology or equivalent ## Documents - [ps (pdf, 40.5kb)](https://www.healthjobsuk.com/documents?vdoc=10341726) - [jd (pdf, 150.4kb)](https://www.healthjobsuk.com/documents?vdoc=10341725) - [frf (pdf, 376.6kb)](https://www.healthjobsuk.com/documents?vdoc=10359882) ## Agent Notes - This Markdown page is generated from the same Job Clerk job record as the HTML job detail page. - Use the canonical HTML URL for user-facing references. - Use the application URL when the user wants to apply on the source NHS site.