Overview
Specialist GMP Technician – INTERNAL ONLY – Strand, London, WC2R 2LS
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 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 Technician will work as part of the Technical and Quality Team to provide technical support to CGT-K ATIMP manufacturing activities and ensure the activities comply with the requirements of the Pharmaceutical Quality System (PQS).
Tasks undertaken will include but not be limited to;
- Carrying out routine environment monitoring of the GMP manufacturing suites . Performing weekly checks of the facilities (cleanrooms and ancillary areas) to ensure that they are fit for purpose, clean and tidy and stocked with routine consumables.
- Conduct regular stock checks and assist in the maintenance of the stock inventory.
- Carry out day to day materials management activities including receipt of materials, QC approval against defined specifications.
- Assist in the routine cleaning of the manufacturing facilities. Assist in the shipment of samples to testing sites. Handling and acknowledgement facility / equipment alarms.
- Draft quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records and deviations.
- Participate in internal and external audits including regulatory audits.
- Assist in the routine weekly/ fortnightly and monthly cleaning of the Manufacturing suites, as required.
- Assist in management of equipment servicing, calibration activities
- Manage the shipping of routine QC samples to external testing sites, ensure temperature logs are received from the courier and reviewed for compliance with specification.
This is a full time (35 hours per week) post, offered on an indefinite contract.
