Skills and Abilities - Workspace

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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:
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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
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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
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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
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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.
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