GMP Technician

Location: Denmark Hill Campus

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. D 
• 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 post (35 hours per week), and you will be offered an indefinite contract.

About you

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

Essential criteria

• Secondary Education to A level or equivalent
• Experience in maintaining databases or tracking spreadsheets 
• Experience in stock management and /or inventory systems
• Experience in liaising with suppliers or service providers 
• Hands-on experience of environmental monitoring in a GMP cleanroom setting
• Experience in cleaning/ decontamination of GMP cleanrooms/ controlled environments
• Basic knowledge of a formal quality system. Experience in working to SOPs or written formal instructions
• Excellent organisational skills with demonstrable ability to balance competing demands and priorities. Ability to work both in a team and independently. Excellent interpersonal and communication skills

Desirable criteria

• Working knowledge of QA/QC in relation to production of IMPs in particular Change Control, Document Control, Process Validation, Equipment Management CAPA, Quality Risk Management
• Experience of working in or maintaining a cleanroom environment

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, provided at the bottom of the next page after you click “Apply”. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

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