GMP Production Technician
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.
• 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.