Advanced Therapies Facility Technician - 57966 - Advanced Therapies Facility - Band 500

Location
Birmingham
Salary
Competitive
Posted
Jul 04, 2019
Closes
Jul 17, 2019
Ref
190000J7
Contract Type
Full Time
Job Type
Technican
Position Details

Advanced Therapies Facility, College of Medial and Dental Sciences

Starting salary is normally in the range £22,722 to £24,411. With potential progression once in post to £28,259 a year.

Full time

Fixed term contract until 14 April 2020

Closing date: 16 July 2019

Job Summary
This post is based within the Advanced Therapies Facility (ATF) which houses both the Human Biomaterials Resource Centre (HBRC) and the GMP Manufacturing Facility (GMP-MF). The HBRC is an HTA licensed, ethically approved human sample biorepository providing sample procurement, processing, analytical and hosting services to biomedical research groups both in academia and industry. The GMP-MF is currently producing cell-based therapies for clinical trials. The ATF is a quality controlled environment highly regulated by both the MHRA and the HTA.
This position will support activity across the ATF and the post holder will be trained to cover both the HBRC and GMP-MF. Within the HBRC, the post holder will undertake the procurement and processing of biomaterials from patients in a wide range of disease settings for release or storage for biomedical research. In addition he/she will be delivering sample analytical and hosting services including samples collected from patients on clinical trials. They may be responsible for the oversight and delivery of all services associated with specific individual projects or collections. Within the GMP-MF, the post-holder would be supporting the production and quality teams in all aspects of production, quality assurance, quality control and facility maintenance. It is vital to have adequate staff capacity within the GMP-MF to enable manufacture for clinical trials to continue (according to strict protocols, timelines and quality standards compliant with the regulations) during periods of increased activity, annual leave or sickness.
The ATF has developed into a key facility helping to deliver translational research programmes which are central to the College research strategy. This specialist post is varied, requires a strong sense of initiative, and knowledge and experience of the applicable regulations. Good communication and interpersonal skills are essential to interact with academic, clinical and surgical staff, often with patients, engineers and visitors in order to correctly interpret and communicate problems in a timely manner. The post-holder must have the ability to work to strict timelines, but also flexibly, since priorities can alter quickly due to changes in patient scheduling. Some out of hours work may be required on occasions.

Main Duties

It is a requirement for regulatory compliance that procedures within the ATF are carried out according to strict Standard Operating Procedures which comply with all current regulations, legislation and clinical, research and information governance arrangements.

WITHIN THE HBRC

• To undertake the procurement of consented human biomaterials and subsequent processing, release or storage. This will involve the retrieval of fixed or fresh tissue samples from operating theatres or cellular pathology departments around the West Midlands, and the collection of blood samples and other body fluids from various hospital settings and subsequent processing. It will also involve the packing and dispatch of samples being released to biomedical researchers at external institutions. The post holder will be involved in the identification and recruitment of appropriate patients as well as control subjects from a number of NHS Trusts around the West Midlands, and will be responsible for the oversight and delivery of specific individual projects or collections. This will involve interaction with patients, clinicians, surgeons and researchers. The post holder will also be responsible for obtaining informed consent on an occasional basis.
• To contribute to delivery of the HBRC processing and analytical services e.g. tissue processing, sectioning, staining, microarray construction, cell and tissue culture, immunohistochemistry and nucleic acid extraction. This requires a wide range of advanced technical skills and will involve regular interaction with basic and clinical researchers and cellular pathology staff. He/she will be expected to advise on sample processing and analytical protocols and so be involved with study design, as well as analysis and interpretation of research data. They may be responsible for the oversight and delivery of all services associated with specific individual projects or collections. Attendance at relevant workshops and user/network groups will be encouraged to enhance knowledge, and to advance the technical capabilities of the HBRC service.
• Management of clinical trial samples received by the HBRC. This involves processing and storing samples according to clinical trial study protocols and associated SOPs. The post holder will be required to work closely with clinical trial co-ordinators and data managers (often multi-centre) to ensure that smooth processes are developed at set up, to co-ordinate the safe delivery of trial samples, and to ensure tasks are completed, often within tight deadlines. All procedures are required to be carried out in a manner compliant with Good Clinical Practice (GCP).
• Accurate completion of all necessary records and electronic sample tracking logs in all areas of activity so that sample traceability is maintained at all times. This is crucial for both HTA and GCP compliance.
• To assist with the collation of patient demographic and clinical data from medical records and clinical forms. This may involve searching NHS Trust clinical databases or paper health records, reading clinical reports and clinic letters and laboratory results to capture relevant project-specific information. To prepare accurate, complete and anonymised reports for researchers. This may also involves identifying and resolving any missing or incomplete data.

WITHIN THE GMP-MF

• To assist with the production of therapies and the quality control tests required for their release. This may involve cell culture and selection within the sterile clean room suite, controlled rate freezing, thawing and storage of products, flow cytometry, endotoxin analysis and sterility testing. Some tests are carried out off site and the post holder will be responsible for organising the transfer of samples and maintaining audit trails of samples and returned results.
• Maintenance of the clean room suite, associated laboratories and ancillary areas to standards compliant with GMP and HTA regulations. This will involve specialised cleaning and environmental monitoring on a daily, weekly and monthly basis, and trending of environmental results.
• Maintenance of equipment contained within the clean room suite, associated clean laboratories and ancillary areas used during the production, quality assurance/analysis and storage of cellular products. This will involve daily monitoring checks of air pressures, air particles, temperature, humidity and CO2 levels. Daily/weekly calibration checks to ensure all equipment remains within specification. The post holder will also be expected to assist with removal of malfunctioning equipment and return to service following planned preventative maintenance or repair.
• To assist with the receipt and completion of goods inward, stock rotation and disposal of items according to GMP regulations.
• To complete and maintain all appropriate records and documentation associated with their duties (paper and electronic) according to GMP regulations.
• To participate in the development, validation and implementation of new projects.
• To be responsible for basic housekeeping matters within the facility laboratories.
• To contribute to the Quality Management System within the ATF, involving the review and validation of new SOPs, risk assessments and COSHH assessments. Reporting of deviations and change controls and risk assessments as required. To contribute to internal and external audit procedures, and to regulatory inspections.
• Any other duties within the ATF commensurate with the grade and skill base of the post holder as directed by the Head of Infrastructure & Facilities and/or the Director of the facility.

Knowledge, Skills, Qualifications and Experience Required

• BTEC or BSc in a biological subject or equivalent relevant experience.
• Knowledge of the regulations, legislation and governance arrangements applicable to clinical research which uses patient samples and data, clinical trials, and surrounding the manufacture of cell-based therapies. An understanding of working within the NHS environment would also be an advantage.
• Experience of handling and processing human blood products, tissues and cells; aseptic cell culture and cryopreservation, preferably in a regulated environment e.g. licensed tissue bank, GMP production facility.
• Knowledge of environmental/skin micro-organisms and procedures to remove them.
• Must demonstrate a critical and intelligent attention to detail, high standards of accuracy.
• Ability to work independently, but also an aptitude for providing effective support for others and where necessary cover other areas of work; a team player.
• Ability to prioritise tasks, and work flexibly, in order to ensure continuity of service in a time-pressured and changing environment.
• Ability to diagnose and resolve problems and suggest solutions in own area with consideration for the ATF as a whole.
• Willingness and aptitude for learning and applying new skills, and to take responsibility of a particular area which will involve training other staff members.
• Must demonstrate effective communication and inter-personal skills and an ability to deal with colleagues and external stakeholders e.g. research staff, engineers, hospital staff, with tact and courtesy.
• Familiar with health and safety requirements/policies relating to handling biological materials, chemical substances and liquefied gases.
• Working knowledge of data management and information systems e.g. sample logging software, clinical databases.
• Knowledge of MS word, Excel and Power Point with the ability to organise data.
• Ability to analyse information and communicate results/issues effectively.
• Positive service attitude and ability/willingness to work outside of normal hours.

Informal enquires to Wendy Thomas. w.a.thomas@bham.ac.uk

http://www.download.bham.ac.uk/vacancies/jd/MDSFPs.pdf