Advanced Therapy Production Scientist
London, England, United Kingdom Full-time Posted 1 week ago
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.
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.
For further details / informal visits contact: Name: Sandeep Kumar Job title: Head of Advanced Therapy Production Email address: Sandeep.kumar24@gstt.nhs.uk Telephone number: 02071887188
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
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.
- 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.
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.
For further details / informal visits contact: Name: Sandeep Kumar Job title: Head of Advanced Therapy Production Email address: Sandeep.kumar24@gstt.nhs.uk Telephone number: 02071887188
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
