Job description

Role purpose

The Centre for Gene Therapy and Regenerative Medicine (CGTRM) manufactures ATMPs for a wide variety of novel gene and cell therapies for the treatment of cancers to rare diseases. This is 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.

The post holder will work with the production or quality team and be involved in supporting the production or testing of Investigational Medicinal Products (IMPs) and Specials. The post holder will be mainly responsible for assisting aseptic manufacturing processes in grade A environment, preparing productions including cleanrooms and equipment, and filling in of documentations in line with the Pharmaceutical Quality System requirement. In addition, on a periodic basis, the post holder may be required to provide administrative support for document control or quality control or substitute for GMP Technician/Scientist, in their absence.

We are looking for a highly-motivated individual who is interested in working in a GMP manufacturing facility. Biological or pharmaceutical background and previous GMP experience is highly desirable, but not essential. Ideal candidate should have excellent organisational skills and good attention to detail. The candidate should understand and be trained in housekeeping activities including medium preparation, sterilisation in autoclave, equipment calibration, maintenance, decontamination, environmental monitoring and routine operations to ensure cGMP compliance. Experience in MS Office computer skills would be essential to create, access and submit reports for review and approval.

Role profile

The GMP Technician is required to assist with production, quality and document control plus other activities in compliance with GMP, including:

- Working closely with Production staff for the preparation of the materials required for batch manufacture of ATMPs in GMP clean room, including room quarantine, pre- and post quarantine.

operations, transfer of passed raw materials, GMP documentation, equipment and FMS monitoring system checks.

- Will be trained in performing environmental monitoring (EM) activities and daily checks within the GMP clean rooms.

- Will be trained to comply with approved Standard Operating Procedures (SOPs) and complete trained activities for handling deviation/ Corrective and Preventive Actions (CAPA) in compliance with Pharmaceutical Quality System (PQS).

- Will be trained to carry out revalidations of procedures, operator validation training and equipment maintenance or validation checks on a regular basis.

- Will be trained to support the Document Controller, ensuring all incoming raw materials are checked against approved Raw Material Specifications and passed to Quality for approval and raw materials stored at designated location/temperature as passed/quarantine/rejected materials in accordance with approved procedures.

-Will be trained to support Document Controller and other GMP staff in their administrative activities such as filing of Supplier Questionnaires.

This post will be offered on a fixed-term contract for 19 months in the first instance

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

Key responsibilities

Key Objectives:

• Provide a range of technical and administrative support to GMP Facility staff, working within established service standards and protocols, to ensure the smooth running of daily activities and GMP compliance.

• 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.

• Provide administrative support to GMP staff and Document controller with site start-up activities including preparing details of a variety of procedures to ensure GMP compliance.

i.e. qualification of clean rooms, cleaning and disinfection, environmental monitoring, daily facility monitoring checks etc.

• Provide cover in the absence of GMP staff or Document Controller to ensure administrative support to facility technical staff and servicing of team meetings. The successful candidate will be trained in administrative duties to ensure completion of tasks for GMP compliance, including the completion of relevant forms and reports.

• Once checked by the relevant staff, store incoming raw materials at the appropriate temperature and file relevant records and certificates. Report any problems or inconsistences to relevant staff.

• Routine checks for equipment calibration/maintenance status as instructed. Provide advice and guidance and, where appropriate, training.

• Follow local procedures to adhere to Pharmaceutical Quality Systems (PQS) and support facility staff in achieving high quality standards for service and execution to ensure GMP compliance.

• Support facility staff in ensuring compliance of clean room preparation and quarantine procedures

• Support the quality team in the compliance of electronic quality systems

• Resolve routine, non-critical problems that arise within the GMP facility, referring to approved GMP compliant procedures, and report problems requiring attention to Technical staff or CCGT management immediately.

• House keeping activities of laboratories, including regular cleaning and maintenance of relevant stocks and other essential laboratory items

• Maintain up-to-date and accurate documentation records and laboratory reports, where applicable.

• Use data analysis skills to analyse and interpret research data and draw conclusions on the outcomes.

• Follow local procedures and comply with quality risk management principles in all aspects to ensure product quality, patient safety and GMP compliance.

• Contribute to ideas for improving current working methods and procedures affecting performance and in meeting objectives of the team.

• Work with colleagues and network as agreed by the line managers

• 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.

A more comprehensive overview of the key responsibilities may be requested from Heather Kneale – heather.kneale@kcl.ac.uk

Skills, knowledge, and experience 

Essential criteria

Qualifications and Training

1.       Minimum level 3 qualification, e.g. A levels, AS levels, International Baccalaureate diploma or other Level 3 qualification, plus work experience in relevant technical/scientific posts OR Considerable knowledge and skills gained through work experience in relevant technical or scientific posts. 

2.       Evidence of an active commitment to career development, such as professional registration with relevant organisations, undergoing practical , on the job training within a life sciences laboratory or clear progression in increasingly demanding jobs. 

Skills / Experience

3.       Experience of working in a life sciences laboratory and an ability to apply learnt techniques to the work context (I). 

4.        Experience in providing administrative support (I). 

Knowledge

5.       Basic understanding of gene therapy (particularly AAV) 

6.       Basic understanding of Good Manufacturing Practice (GMP).  

Competencies

7.       Good record keeping and attention to detail. Competent in managing and handling electronic or paper-based documentation. (I). 

8.       Clear spoken and written communication skills, with proficient computer use and strong interpersonal skills when working with internal and external stakeholders. (I). 

9.       Experience in operation of production equipment for AAV adherent/suspension technologies, cell disruption, chromatographic purification, concentration/diafiltration, final vial filling) Experience in in providing administrative support for GMP facility start-up from facility and equipment qualification to development, validation and GMP manufacturing (AP, I). 

10.   Experience in providing administrative support to the production and quality control team; and working with a team comprising of production, development, QC and quality assurance staff, including interactions with internal and external stake holders (AP, I). 

11.   Experience in providing administrative support to the team to meet timelines for batch manufacturing and release of gene therapy products for clinical trials (AP, I). 

Desirable criteria

12.   Experience in process development, manufacturing and release of AAV gene therapy products.(AP, I) 

13.   Experience in managing the production team and working with a team comprising of development, production and quality assurance staff for coordinating milestones related to quality assurance, manufacturing, audits (internal, external and regulatory), and successful interactions with internal and external stake holders, leading to GMP inspection readiness and approval (AP, I). 

14.  Able and willing to provide support beyond core hours, as required.