GMP Production Technician - College of Medical and Dental Sciences

Position Details

Advanced Therapies Facility

College of Medical and Dental Sciences

Band 500

Full time 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 Post

Fixed term

Closing Date: 3 November 2019

Job Summary

The post is based within the Advanced Therapies Facility (ATF) in the College of Medical and Dental Sciences where therapies are manufactured for administration into patients enrolled on clinical trials or receiving specialist clinical treatments. The ATF is a quality controlled and highly regulated environment. The manufacturing suite must remain compliant with the Good Manufacturing Practice (GMP) regulations and is licenced by the MHRA.

The main role of the post holder is to support both the Production Manager and Quality Assurance Manager in all aspects of production, quality assurance and facility maintenance. He/she would also be expected to cover these roles during periods of annual leave or sickness. This is vital in order to allow manufacture and product release to continue.

The post holder must be able to work independently and will be expected to carry out the day-to-day maintenance the facility and equipment (including environmental monitoring programmes, specialist cleaning, equipment maintenance, stock rotation) and will also assist with the training and supervision of external research staff (e.g. gowning validation, clean room entry and cell production). This specialised role requires an in depth knowledge and experience of working within a GMP facility, proactive planning and time management skills and also reactive management flexibility as needs can often change due to production deadlines. Good communication skills are required to interact with staff, engineers and visitors to the department and to correctly interpret and communicate problems in a timely manner. The post holder will also assist with writing and review of standard operating procedures and raise deviations/non-conformance as they develop.

Some out of hours work may be required to maintain production deadlines.

Main Duties

• To assist with the production of therapies and the quality assurance tests required for their release. This may involve cell culture and selection within the sterile clean room suite, manufacture of therapies within associated clean laboratories, 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. During periods of absence the post holder will be expected to cover the Production Manager and Quality Assurance Manager in all aspects this work to enable manufacture and product release to continue.

• Maintenance of the clean room suite, associated clean 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, and the analysis and trending of data produced by the Tutela monitoring system. 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. Supervision of engineers on site to repair, maintain and service equipment.

• To undertake 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. This will involve the training and supervision of external researchers in clean room validation and procedures, and will include production, testing and release processes according to study-specific protocols.

• 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 Director of the Facility and/or Operations Manager (Infrastructure).

Person Specification

• BTEC or BSc in a biological subject or equivalent relevant experience.

• Knowledge of the regulations, legislation and governance arrangements surrounding the manufacture of cell-based therapies to patients on clinical trials and receiving specialised treatments.

• Experience of working in a cell manufacturing facility to standards of Good Manufacturing Practice and Good Clinical Practice, including the use of specialised equipment to select, quality assure, freeze and thaw cell based therapies.

• Excellent aseptic human tissue processing and cell culture skills, and in particular a sound 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 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.

• Knowledge of MS word, Excel and Powerpoint with the ability to trend and organise data. Ability to analyse information and communicate results effectively.

• Positive service attitude and ability/willingness to work outside of normal hours.

The University is committed to safeguarding and we promote safe recruitment practice, therefore all associated pre-employment checks will be undertaken before any appointment is confirmed.

We value diversity at The University of Birmingham and welcome applications from all sections of the community'