Advanced Therapy Production Scientist

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.