Cell Therapy Unit GMP Laboratory Technician

This post will be located in the Cell Therapy Unit of the Clinical Research Facility. This technician post will be based within the GMP manufacturing facility based on the 2nd floor of the Clinical Research Facility which is a King's Health Partners venture based on the Denmark Hill Campus.

The successful candidate will report to the CTU Quality Director and play a key role in relation to the operation of the facility, supporting the work of a number of Cell and Gene Therapy groups manufacturing and processing cells and tissues for human use under both the regulation of the Human Tissue Authority (HTA) and the Medicines and Healthcare products Regulatory Agency (MHRA). A good knowledge of GMP and working in GMP clean rooms is required.

The post requires the holder to have working knowledge of the operation of GMP clean rooms and basic cell processing equipment including isolators, biological safety cabinets, incubators, microscopes, and balances. The post includes day-to-day supervision, maintenance, and monitoring of the cleanrooms, stock room, QC laboratory, and the equipment within it.

Main duties of the job

1. Conducting routine environmental monitoring of the facility to Standard Operating Procedures.
2. Conducting routine performance qualification (particle monitoring, airflow calculation, pressure differential calculation) of the cleanrooms to SOP.
3. Conducting or supervising routine equipment cleaning, maintenance, calibration, and revalidations to Standard Operating Procedures and Pre-approved Protocols.
4. Routine cleaning of the facility to Standard Operating Procedures; where necessary, supervising facility cleaning to Standard Operating Procedures.
5. Ensure adequate stock of required clean room garments, approved consumables, and reagents are available for manufacture.
6. Replenish/order when stock is low or as requested - Stock control, check expiry dates, keep stock control organized.
7. Assist/perform routine maintenance & calibration of equipment in GMP clean rooms and QC labs.
8. Providing assistance and basic training for equipment and facility for new users and existing groups.

About us

King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of £1 billion, 1.5 million patient contacts a year and more than 11,500 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in Bromley.

King's College Hospital NHS Foundation NHS Trust is currently delivering an ambitious financial efficiency programme with the aim to achieve long-term financial sustainability.

Job description

The Good Manufacturing Practice Facility Cell Therapy Unit (CTU) on the Denmark Hill Campus of Kings College London (KCL) seeks to appoint a GMP Laboratory Technician. This exciting post reflects NHS and academic research collaborations between Kings College London and Kings College Hospital, which come together under the Academic Health Sciences Centre (Kings Health Partners). The appointee will be working under the direction of the CTU Quality Director, with day-to-day direct responsibility for running of the CTU and reporting to the CTU Quality Manager and CTU Senior Technician.

The successful candidate will have proven experience of supervising and carrying out monitoring and maintenance of a cleanroom facility to HTA and MHRA standards, as well as experience in stock control.

Person Specification
Knowledge and Experience
Essential

• Experience of working in and day-to-day management of GLP Quality Control Laboratories.
• Ability to communicate effectively with researchers.

Desirable

• Has knowledge of undertaking a risk-based approach using analytical methods e.g. FMEA/HACCP.
• Experience of working in and day-to-day management of GMP Clean rooms.
• Experience of working in a Cellular Therapy or Good Manufacturing Practice environment regulated by the HTA and MHRA.

Education and Qualifications
Desirable

• HND or BSc degree in relevant subject area (covering basic molecular and cell biology), or equivalent vocational qualification and equivalent experience in GMP Clean Room and QC laboratory management.

Skills and Competencies
Essential

• Effective time management and organizational skills.
• Excellent record keeping, attention to detail.

Employer details
Employer name
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
London
SE5 9RS
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