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GMP Facility Officer

2 months ago

London, Greater London, United Kingdom King's College London Full time

About us

The King's College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages.

In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.

The GTVF is run by a large, industry-leading team of >50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trials.

About the role

The Cell and Gene Therapy, King's (CGT-K) group manufactures a variety of Advanced Therapy Investigational Medicinal Products (ATIMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for the treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.

The GMP Facility Officer will work as part of the Facilities Team to ensure the CGT-K GMP facilities are fit for purpose and maintained in a manner to support the ATIMP and viral vector manufacturing activities. The role holder will also work closely with the Quality Assurance (QA) team to ensure the CGT-K facilities comply with the requirements of the Pharmaceutical Quality System (PQS) and with the Production team to ensure the manufacturing schedule can be maintained.

The GMP Facility Officer will be responsible to the GMP Facility Manager.

This would be an excellent position for someone who wishes to develop a career within the operational management and maintenance of GMP cleanroom facilities.

This is a full time post, and you will be offered a fixed term contract for one year.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

  • Educated to degree level or equivalent
  • Experience in liaising with external and internal suppliers, contractors, service providers or stakeholders
  • Experience of working in or maintaining a cleanroom environment and validation
  • Experience in equipment IQ/OQ, routine maintenance and / or calibration
  • Working knowledge of formal quality systems for change control and deviations, and working to SOPs or written formal instructions, CAPA, Quality Risk Management, data integrity
  • Excellent organisational skills with demonstrable ability to balance competing demands and priorities. Demonstratable experience of problem solving
  • Experience of writing health and safety risk assessments and COSSH
  • Experience in maintaining databases, tracking spreadsheets or inventories

Desirable criteria

  • Working knowledge of a facility monitoring system

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, via the above 'Apply' button. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Closing date: 08 July 2024

£37,332 to £42,099 per annum, including London Weighting Allowance.