The Centre for Cell and Gene Therapy (CCGT) 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 house-keeping 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.
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 30 months in the first instance
This is a full-time post - 100% full time equivalent
Skills, knowledge, and experience
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).
5. Basic understanding of gene therapy, bioprocessing or GMP manufacturing
6. Skilled in basic microbiological techniques (I).
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. Working knowledge of regulations and best practice governing area of work, including Health & Safety and environmental sustainability.
1. Experience in supporting quality and/or manufacturing team for implementation of electronic quality documentation and electronic batch records respectively (AP, I).
2. Experience in providing administrative support for process development, manufacturing and release of products in ongoing clinical trials.
3. Experience in in providing administrative support for GMP facility start-up from facility and equipment qualification to development, validation and GMP manufacturing (AP, I).
4. Experience in providing administrative support to production or quality control team and working with a team comprising of development, QC and quality assurance staff and interactions with internal and external stake holders (AP, I).
5. 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).
Have you worked in a life sciences laboratory?
YES - continue with application
NO - STOP application
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