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 Working under the trusts Pharmaceutical Quality System, the post holder will use their specialist knowledge in Good Manufacturing Practice (GMP) to maintain compliance with regulatory standards and drive continuous improvement. The job will include review and oversight of activities undertaken in both Production and Quality Control groups within the ATMP manufacturing unit, and the preparation of records for authorisation. Deviation management is a key component, using specialist knowledge to develop informed and reasoned decisions regarding the disposition of products and tests. Main duties of the job You will ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment. Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results. Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained. Provide trending data used to set alert limits for monitoring control of the environment. Undertake product quality review to ensure that specifications for products are under control, using Six-Sigma analysis, and provide solutions to gain further control where necessary. Work unsupervised managing production and analytical deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production. Provide day-to-day professional supervision and practical training for production and quality control activities and o ngoing supervision of support staff, and new and junior staff. Working for our organisation The Advanced Therapies Manufacturing Unit (ATU) is co-located with the Clinical Research Facility (CRF) at Guy’s Hospital on the 15 th floor of the tower. The ATU 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 or as Specials. It is used for both commercial and non-commercial collaborators as well as departments within GSTT to manufacture ATMPs related to trials undertaken in the CRF and at trial sites across the UK. Detailed job description and main responsibilities Professional Responsibilities Responsible for delivering a highly specialist clinical technical service by leading and managing the quality assurance for manufacturing of cell therapy and gene therapy products for the clinical needs of participants on current and future clinical trials, as delegated by the Head of Advanced Therapy Quality. Working with the core facility team, be responsible for ensuring that quality exception investigations, preventative actions and change control procedures are completed effectively and within agreed timelines. Take professional responsibility for specialist validation activities, including installation and operational qualifications, and ongoing revalidation in accordance with the Unit’s validation master plan. Authorisation of validation reports. · Ensure that records of manufactured and tested products are made according to authorised quality standards. You will lead as a specialist quality assurance officer · Manage the review and acceptance or rejection of raw materials and suppliers of materials and services, keeping an up-to-date review of internal quality systems used to assist in this management. · Take a lead in the qualification of outsourced activities, including audits of contract acceptor quality control sites, and third parties undertaking licensable activities. Responsible for maintaining an up-to-date knowledge-base while demonstrating advanced competencies through a personalised Continued Professional Development portfolio. Capable of working independently and as part of a team of clinicians, scientists and regulatory personnel. An ability to provide and receive complex scientific information is required, as is the ability to make concise and accurate input to regulatory submissions. Therefore, you will have good organizational and communication skills with proven record of scientific achievements. Required to work with users of the GMP Unit to develop continuous quality improvement through a system of self inspections, and supplier and service provider audits. Report result outcomes and provide specialist advice to clinicians, investigators and scientists in clinical development. Contribute to the development of this specialist service through technical transfer and process development of novel Advanced Therapy Medicinal Products (ATMPs) within the BRC GMP Unit. You will take responsibility for developing and implementing independently controlled documents: Product Specification Files, Batch Manufacturing Records and Standard Operating Procedures (SOPs) for Production activities in the GMP unit. Management and Leadership Responsibilities Communicate with colleagues about specialist complex manufacturing procedures, explaining complex and sensitive information such as: results to clinicians and other service users; advising clinicians over appropriate production methods to use; undertaking interpretation of results related to the organisation. You will bring innovation and development to the role, ensuring that the service provided by the Unit remains world-leading. Disseminate research and specialist technical knowledge. You will attend and lead in presenting at R&D meetings, seminars and national or international meetings where deemed appropriate. Plan and prioritise the specialist quality assurance service workload, liaising with other departments, and suppliers in relation to manufacturing and testing ATMPs. You will interact with the Unit’s capacity planning system to ensure the smooth running of the Unit. You will be required to design complex activities with specialist technical services many months ahead. Work unsupervised managing production and analytical deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production. Provide day-to-day professional supervision and practical training for production and quality control activities and o ngoing supervision of support staff, and new and junior staff. Make informed decisions relating to manufacturing and testing activities as delegated by the Head of Advanced Therapy Quality to create standard procedures that ensure compliance with legislation and Trust requirements. You will be expected to contribute to supervision and training of junior scientific and support staff working in the GMP Unit. Quality Assurance Process Responsibilities: Using specialist experience in Good Manufacturing Practice and the standards for the Quality and Safety of Tissues and Cells for Human Application you will develop production and analytical methods involving closed cell processing, primary cell culture, immunomagnetic depletion (MACS), FACS and proliferation methods during technical transfer to the GMP Unit, and post-authorisation roll-out of production for clinical trials. Develop highly specialist knowledge of GMP quality assurance as applied to ATMPs, underpinned by theoretical knowledge and experience of cell biology. Work collaboratively with internal and external customers to understand a range of complex facts and situations requiring analysis, interpret and compare ranges of options to facilitate process development within the GMP Unit to optimise the process under GMP conditions and provide data for inclusion in regulatory submissions. You will think strategically, ensuring that the GMP Unit is used efficiently to maximise its utility. Work collaboratively with internal and external customers to undertake production and analytical qualification under GMP conditions and provide data for application to the regulatory authorities. You will ensure adequate maintenance and supervision of equipment, and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment. Undertake strategic judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results. Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained. Provide trending data used to set alert limits for monitoring control of the environment. Undertake product quality review to ensure that specifications for products are under control, using Six-Sigma analysis, and provide solutions to gain further control where necessary. Computer competency in quality management software is essential. Operate within the Pharmaceutical Quality System: In reviewing temporary changes, you will assess the impact of a change on the manufacturing or testing process prior to its implementation. You will report deviations through Quality Exception Reports to line managers. You will undertake Preventive Actions and Change Controls to rectify exceptions and implement audit and inspection findings. Where directed or delegated by the Head of Advanced Therapy Quality, you will develop specific, accurate, precise and robust specialist Quality Control assays to be used following cell and gene therapy production. · Assist in the management and monitoring of Quality Assurance and Quality Control activities, ensuring that agreed quality standards of service are maintained. You will enable preparation of quality data to be used in the certification of ATMPs. Documentation Responsibilities: Using your specialist knowledge you will undertake the development and generation of: Unit-specific SOPs and policies relating to quality assurance operations. These must comply with GMP and the Unit’s manufacturing licence. Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs. Product Specification Files or Preparation Process Dossiers for cell therapies. · Undertake documentation control procedures, using database systems to track GMP documentation. You will work autonomously to Standard Operating Procedures and protocols. Person specification Knowledge/Qualifications Essential criteria BSc degree in cell biology or equivalent Evidence of courses and ongoing specialist training for GMP and validation activities 3 years QA track record in clinical or medical research Desirable criteria Has undertaken research in Immunology, Haematology or equivalent experience Undertaking training to become a EU QP Experience Essential criteria Specialist experience in quality assurance activities in a regulated environment Expert knowledge and hands on experience of Good Manufacturing Practice GMP Experience with process qualification, and equipment validation for GMP Excellent troubleshooting and data presentation skills Ability to organise resources and planning Expert in controlled documentation and record keeping as well as generation of SOPs Desirable criteria Specialist knowledge relating to the manufacture of somatic cell and gene therapy products within GMP Experience in cellular immunology techniques and analyses: proliferation, characterisation, and safety tests Specialist knowledge of: environmental monitoring, GMP unit cleaning, maintenance and qualification of specialist equipment Skills Essential criteria Ability to work independently Ability to participate in the organisation of the GMP unit Ability to communicate complex ideas verbally and in writing. Ability to work collaboratively and as part of a team Specialist experience with assay optimization, validation Desirable criteria Specialist knowledge of deviation management within a pharmaceutical quality system Experience in training staff and students Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership. Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy. As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends. Flexible working We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process. Your e-mail address is important to us - We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis. Please apply for this post by clicking "Apply Online Now." Further details / informal visits contact Name Sakina Gooljar Job title Head of Advanced Therapies Quality Email address [email protected] Telephone number 02071887188 Additional information Telephone Extension 52703