Job summary
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
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Lead in the manufacturing of advanced therapy medicinal products
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Ensure that the unit is always well stocked
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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
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Qualify, process validate and re-validate equipment and GMP procedures successfully
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Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained.
About us
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.
Job description
Job 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 units 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 SOPs 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 Trusts 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 Trusts Equal Opportunities Policy and equality laws.
Please review Job description document for full responsibilities.
Job description
Job 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 units 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 SOPs 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 Trusts 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 Trusts Equal Opportunities Policy and equality laws.
Please review Job description document for full responsibilities.
Person Specification
Qualifications
Essential
- BSc in Immunology, Haematology or equivalent experience
Desirable
- PhD and/or MSc in Immunology, Haematology or equivalent
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
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
Person Specification
Qualifications
Essential
- BSc in Immunology, Haematology or equivalent experience
Desirable
- PhD and/or MSc in Immunology, Haematology or equivalent
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
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
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
