GMP Technician

Job id: 080826. Salary: £37,332 -£39,980 per annum, including London Weighting Allowance.

Posted: 08 December 2023. Closing date: 08 January 2024.

Business unit: Faculty of Life Sciences & Medicine. Department: Gene Therapy and Regenerative Medicine.

Contact details:Heather Kneale. [email protected]

Location: Guy's Campus. Category: Professional & Support Services.

The Gene Therapy Vector Facility (GTVF) group at King’s College London manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for the treatment of cancer and rare diseases.

This post, which is supported by an Innovation Hub for Gene Therapy grant awarded to the KCL Centre for Gene Therapy for Regenerative Medicine, provides an opportunity to work within one of the largest academic GMP facilities in Europe focusing on the delivery of gene therapy products for early phase clinical trials. This post will support the translation of cutting-edge medical research into clinical application.

The GMP Technician will work as part of the Adeno-Associated Viral Vector (AAV) group to provide technical and facility support. The post hold will support to ensure manufacturing activities comply with the requirements of the Pharmaceutical Quality System (PQS), and with UK and EU Good Manufacturing Practice regulations.

Task undertaken will include but not be limited to:

• Conduct regular stock checks and assist in the maintenance of the stock inventory.
• Carry out day to day materials management activities including purchasing, receipt of materials, and QC approval against defined specifications.
• Assist in the shipment of samples to testing sites.
• Carrying out routine environment monitoring of the GMP manufacturing suites
• Assist in the routine cleaning of the manufacturing facilities.
• Organization and booking of engineer and service provider routine equipment and facility maintenance, service and annual requalification visits and emergency repair visits.
• Liaising with KCL estates to ensure engineer permits to work are issued.
• Ensure the planned preventive maintenance is carried out as per the schedule and the tracking system is kept up to date.
• Carryout in-house equipment calibrations and IQ/OQ
• Assist in the maintenance of equipment records in accordance with the PQS.
• Undertaking daily logging of equipment and facility temperatures, including handling and acknowledgement of facility / equipment alarms on the Facility Monitoring System, as required.
• 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.
• Support investigation of facility and environmental out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Quality Assurance team.
• Draft quality system documentation including but not limited to Standard Operating Procedures and Batch Manufacturing Records.
• Participate in internal and external audits including regulatory audits.
• Undertake administrative duties within the CGT-K including taking of meeting minutes and filing of documentation

The GMP Technician will report to the Head of AAV, and will work alongside members of the Quality, Production, Quality Control and Technical teams.

This post will be offered on an a fixed term contract for 18 months in the first instance.

This is a full-time post - 100% full time equivalent.

• Perform routine Environmental Monitoring (EM) activities, including reading the EM plates and media fill samples, raising deviations for any Out of Specification (OOS) results.
• Send Out of Specification (OOS) EM plates and media fill samples to an external contactor for identification, and file the reports within the PQS, including maintaining the database of samples sent for identification.
• Support investigations related to OOS routine EM samples, implementing corrective and preventative action in conjunction with the QA, QC, Production, Technical and Facility teams, and closing quality exceptions in a timely manner.
• Assist in the routine weekly/ fortnightly and monthly cleaning of the Manufacturing suites, as required.
• Perform the cleaning, packing and sending of items for sterilisation at a third-part contractor, including the receipt and approval of the sterilised items on their return.
• Managing of laundry including receipt and packing for sending.
• Assist in the shipping of routine QC samples to external testing sites, ensure temperature logs are received from the courier and reviewed for compliance with specification.
• Perform weekly checks of the facilities to ensure that they are fit for purpose including cleaning and tidying of the area; and restocking of the area with cleaning items, garments and consumables. And assist QA with the weekly facility authorisation.
• Perform the management and control materials, including checking stock levels, updating the inventory; purchasing materials, and receipt, inspect and approve materials for use.
• Engage in Continuing Professional Development and training initiatives. Undergo training and follow instructions for completing periodic staff qualification and training records related to house-keeping procedures and GMP compliance activities.
• Contribute to ideas for improving current working methods and procedures affecting performance and in meeting objectives of the team.
• Ensure equipment and facilities are serviced as per the planned preventative maintenance schedule including booking engineer routine maintenance, requalification and emergency repair visits.
• Liaise with KCL estates to ensure engineer/ service provider permits to work are issued including any inductions, accompanying the engineers into the cleanrooms/ controlled areas including cleaning in of the engineer’s equipment.
• Perform daily logging of equipment and facility temperatures and perform daily acknowledgement of facility / equipment alarms on the Facility Monitoring System (FMS), as required. Ensure equipment and facility records are maintained in accordance with the PQS. And support any data backup in conjunction with QA.
• Notify staff of out of use equipment, labelling equipment and bringing the equipment back in to use as per the standard operating procedure.
• Carryout in-house equipment calibrations or qualification works, as needed.
• Take part in the investigation of facility and equipment alarms, out of specification events and quality exceptions and implement corrective and preventive actions in conjunction with the Facility and Quality Management.
• Draft quality system documentation in a timely manner, including but not limited to Standard Operating Procedures.
• Draft quality system documentation in a timely manner, including but not limited to material specifications and standard operating procedures.
• Participate in internal audits.
• Follow local procedures and comply with quality risk management principles in all aspects to ensure product quality, patient safety and GMP compliance.
• Forge relationships with colleagues in the School, Faculty, university and external to the university, to build relationships, disseminate and get information, coordinate, and deliver the service.
• Communicate information in a clear and precise way, both orally and in writing.
• Manage own workload within the parameters of an-agreed work plan, responding to changing priorities and an evolving environment/context and maximising the efficiency of the technical support being provided.
• Implement local environmentally sustainable practices, following the King’s sustainability audit process, where appropriate. Collaborate with colleagues to share good practice and support wider sustainable initiatives and suggest new ideas where you see that improvements could be made.
• Facilitate an inclusive culture and ethos working with academic, research and other professional services staff and colleagues external to King’s.

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Essential criteria

Qualifications and Training

Skills / Experience

Knowledge

Competencies

Desirable criteria