IMPERIAL COLLEGE LONDON Job Description Job Title: Biobank Research Technician Section: Haematology Division: Experimental Medicine Job Family and Level: Technical Services, Level 3b Salary Range: £32,130 - £39,920 per annum Responsible To: Heads of Processing and Quality Works closely with: JGCCT Head of Operations and Regulatory Affairs Manager Working Relationships: Head of Operations and Regulatory Affairs JGCCT, Medical Director JGCCT, Operations/Regulatory Affairs Manager, Transplant Programme Quality Assurance Manager , Laboratory Quality Advisor (Transfusion Consultant Haematologist), JGCCT Heads of Processing/Quality and Clinical Trials Development, Clinical Trials Department, Trust Pharmacy QA services, Dept. Medical staff Haematology Consultants and Transplant co-ordinators, Nursing staff and other professional colleagues within the Directorate, Imperial College Faculty of Medicine. Location: Hammersmith Campus Duration: 2.5 years Funding: Leuka Summary of Post Within the Imperial College London Healthcare NHS Trust’s Bone Marrow Transplant Unit the John Goldman Centre for Cellular Therapy provides highly specialist clinical, technical and scientific services for monitoring patients undergoing stem cell mobilisation, for the processing of stem cell and other cytotherapeutic harvests, quality control and long term cryogenic storage. In addition to supporting the routine clinical stem cell transplant programme the JGCCT also collaborates on the development and manufacture of new cells based therapies for use in clinical trials. The core clinical activities of the laboratory broadly fall into Processing and Quality Testing. In an increasingly regulated/pharmaceutical environment it is imperative that clinical products produced by the laboratory are ‘fit for purpose’ and are safe for clinical use. Independently the JGCCT also supports the paediatric stem cell transplant programme located at St Mary’s Hospital. In addition to providing material for local research work the JGCCT also operates a research Biobank. The Biobank receives samples from a number of UK centres, samples are processed and cryopreserved, stored samples are made available at national level for approved research studies. In summary, the Biobank Research Technician will: Use and develop specialist skills within the Quality Testing Dept. in order that patient evaluation and product quality testing are carried out appropriately and in a timely manner conducive to good patient management. Use and develop specialist skills within the Processing Dept in the controlled working environment, clean rooms and associated areas, to maintain regulatory compliance and a safe environment for the processing of cell harvests for clinical use. In carrying out these duties, the post holder will maintain close communication with Medical and Nursing staff attached to the Bone Marrow Transplant unit activities based at the Hammersmith Hospital, and the Paediatric team based at St Mary’s Hospital. The post holder will also be actively involved in supporting the Research Biobank both in the receiving and processing of samples, maintenance and support of Biobank cryostorage facilities, requests for samples, sample distribution and data management. Key result areas: Processing and Quality Testing Develop and maintain a high degree of personal knowledge and practical competence in all quality testing methodologies including flow cytometry, viability assessment, clonogenic assays, processing functions (e.g. graft engineering and cryopreservation) and Good Manufacturing Practice (GMP) principles. Maintain effective communication with other professional groups within the transplant unit to ensure that, as far as is possible the laboratory workload can be managed prospectively, that the required documentation/information is available and results are communicated in a timely manner conducive to good patient management. Optimal utilisation of staffing and other resources such that: Processing of haematopoetic progentitor cell apheresis harvests (minimally and extensively manipulated i.e. immunoselection of CD34+ progenitors) Processing of bone marrow harvests (i.e. red cell and/or plasma depletion) Allograft engineering of CD34+ progenitors and other effector cells Cryopreservation of cells using cryoprotectant agents and controlled rate freezing Long term cryogenic storage of cells in liquid nitrogen vapour phase Recovery from cell repositories for tissue release and transplant Preparation of cells on the ward for transplant HPC enumeration of patients undergoing mobilisation HPC dose determination of clinical products T cell doses and characterisation of non-target cells in engineered auto and allograft products Other quality indicators e.g. cell viability clonogenic capacity Collation of all quality-testing results (internal and external) is complete prior to tissue release to the cell bank Recovery from cell banks for transplant and tissue release Quality Check on cells thawed on wards for transplant Facility support tasks Consumable stock control, usage and ordering to minimise wastage and stock running out. Inventory management of cryopreserved cell banks (clinical and research Biobank) including liquid nitrogen supplies and temperature/control monitoring/alarm system. Maintain control systems for the issue of interim results, database management, data entry, issue of CD34 results on mobilising patients Quality Dept. reports and general upkeep of ‘Quality’ records. Laboratory Quality system Review Quality testing/Lab Quality System SOPs and validate to agreed protocols. In conjunction with the JGCCT Heads Quality and Processing and other senior staff, carry out validation and qualification of ancillary materials and equipment. Effective liaison with others (e.g. pharmacy QA services to ensure environmental monitoring) and ensure audit plans are adhered to. Ensure that all Quality Testing adverse events etc are reported in a timely manner and acted upon as necessary. R&D/Clinical Trials In conjunction with, or as directed by the JGCCT Head of Operations and Regulatory Affairs Manager, Heads of Processing and Quality Depts collaborate with Head of Clinical Trials Dept. in development, evaluation and implementation of new procedures. Main Duties and responsibilities Communication Provide and receive information to inform work colleagues or external agencies. This may include providing explanation of results Liaise with Consultant Haematologists, other clinical, nursing, administrative managerial and scientist staff on relevant clinical and related aspects of the service provided by the laboratory Communicate effectively within the laboratory to ensure optimal exchange of operational information between Quality Testing and Processing Depts Promptly communicate any difficulties, conflict or problems affecting the laboratory to the Heads of Depts Laboratory Management Liaise closely with the JGCCT Heads of Processing and Quality to ensure that the activities of both Production and Quality Testing Depts interact effectively, consistently and in line with Laboratory objectives As far as is practicable, schedule quality testing of patient samples e.g. for CD34 cytometry, to facilitate good clinical management of patient’s booked in for apheresis Ensure that a high scientific standard of work is maintained and professional standards are monitored As directed by senior staff, contribute to the operational development of the laboratory in response to clinical demand and organisational change Work economically and efficiently to achieve departmental objectives Quality Management Ensure own areas of activities with the Quality Dept are carried out in accordance with the laboratory quality system. Have input into the review of the quality system Be aware of the regulatory environment that the service operates and is licenced i.e. Human Tissue Authority, JACIE and MHRA expectations and assist in the development of clinical services to Good Manufacturing Practice (GMP) and other relevant regulatory and quality standards Complete quality records re: calibration status, service contracts, NEQAS reports, facility monitoring Be responsible for reporting errors, incidents and adverse reactions to Dept Heads Participate in Quality and Processing Depts. internal and external quality assessment schemes Participate in audit and review of departmental work Scientific, Processing and Quality Undertake processing procedures, graft engineering, cryopreservation, storage and recovery of cytotherapeutic products 1. Automated haematology cell counting 2. Flow cytometry for haematopoietic/lymphoid cell markers 3. Microscopy for cell viability 4. Aseptic working in clean room to prepare stem cells for cryopreservation 5. Cell storage, retrieval and infusion procedures 6. Cryopreservation procedures Undertake specialist processing procedures. Make judgements on procedural detail in line with departmental SOPs 1. Bone marrow processing using a variety of cell separator devices 2. Immunoselection procedures using a variety of immunoselection platforms Working in and maintaining aseptic techniques in environmentally controlled areas Ongoing responsibility for the maintenance of safe cryogenic environment/conditions to ensure frozen tissues are suitable for transplant Develop and maintain specialist knowledge of current scientific/clinical/regulatory developments Provide specialist technical assistance for laboratory procedures i.e. troubleshooting Ensure all laboratory equipment is used safely and maintained Ensure that all departmental policies, including Health and Safety codes of practice, and procedures are observed within a climate of confidentiality Participate in departmental out of hours/emergency rotas Data Management System As delegated by the JGCCT senior staff, participate in implementation and maintenance of dedicated StemLab laboratory information system Responsible for data entry, upkeep of laboratory databases, patients’ records and collection of audit data Develop and maintain a range of IT skills including word processing, spreadsheets and any other relevant software Training and education As necessary deliver training to staff within the department and to visiting medical, scientific and nursing staff Participate in laboratory staff training including completing competency records Maintain personal Health Professions Council (HPC) registration Ensure personal CPD activities are ongoing and portfolio maintained In association with the Dept Heads, agree personal targets and objectives as part of the Trust’s performance review system Local research sample management CML BioBank operation and support In response to local requests for samples carry out searches of or laboratory informatics systems for sample matching the request parameters Reconciling potential sample matches with clinical and consent status of the patient Preparation of release documentation Recovery from storage samples authorised for release Updating storage inventory and laboratory informatics. Provision of data to approved third parties For CML Biobank samples - booking in, sample preparation and cryopreservation of viable cells, storage of frozen plasma samples Updating relevant informatics systems For approved requests for samples held in the Biobank recover from storage and package for transportation Research and development/Clinical Trials/Regulatory Legislation As directed by the JGCCT Head of Operations and Regulatory Affairs/Dept Heads, participate in the development/implementation of new ideas and techniques (e.g. novel immuno-therapeutic cellular/gene therapies) as necessary to keep pace with continually changing work patterns within the Trust and to ensure the continuing provision of a demand led service of the highest calibre Be aware of current regulatory legislation i.e. EU Clinical Trials Directive/EU Tissue Directive requirements for clinical processes, R&D and clinical trials Job descriptions cannot be exhaustive and so the post holder may be required to undertake other duties, which are broadly in line with the above key responsibilities. The post holder is expected to observe and comply with all College policies and regulations, for example Health and Safety, Data Protection etc. Imperial College is committed to equality of opportunity and to eliminating discrimination. All employees are expected to adhere to the principles set out in our Equal Opportunities in Employment Policy, Promoting Race Equality Policy and Disability Policy and all other relevant guidance / practise frameworks. IMPERIAL COLLEGE LONDON Person Specification Qualifications Essential BSc in Haematology, Blood Transfusion or Immunology or a closely related discipline, or equivalent research, industrial or commercial experience Desirable Experience in operating within a Quality Management System Health Professions Council Registration Good Manufacturing Practice (GMP) training FIBMS and/or MSc in appropriate specialist subject Knowledge / Experience Essential Post Graduate experience in Haematology, Blood Transfusion Science or Immunology Experience in managing or supervising laboratory staff, including training and regulatory compliance Desirable Experience of HPC processing and HPC quality testing Experience of training and teaching staff Skills and Abilities Essential Technical aptitude Ability to develop and apply new concepts Creative approach to problem-solving Excellent verbal communication skills and the ability to deal with a wide range of people Excellent written communication skills and the ability to write clearly Ability to organise own work with minimal supervision Ability to prioritise own work in response to deadlines Ability to work consistently to high standards Personal Attributes Essential Willingness to work as part of a team and to be open-minded and cooperative Flexible attitude towards work Discipline and regard for confidentiality and security at all times Willingness to undertake any necessary training for the role Application Guidance Please read the person specification carefully and describe, as part of your application, how much you feel you meet each of the criteria. If you need more space, please attach additional sheets to the application form. The recruitment monitoring section of your application will be detached and will be used only for monitoring and audit purposes as a basis for supporting our commitment to Equal Opportunities. An application form and full CV quoting reference number HM2012113 should be sent, online via the Imperial College iRecruitment website. Shortlisted candidates will be contacted as soon as possible after the closing date. Thank you for your interest in this post. We look forward to receiving your application.