The Cell and Gene Therapy, King's (CGT-K), group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) in state of the art Good Manufacturing Practice (GMP) facilities for novel therapies of different cancers and rare diseases.
The Production Assistant is responsible for supporting the manufacture of different types of Investigation Medicinal Products (IMPs) and “Specials” for cell therapies, but especially viral vectors used in clinical trials, by taking care that the documentation, materials, equipment and facility are ready for use. That includes for example reviewing and updating GMP documents like Standard Operation Procedures and forms, validating equipment and completing corresponding reports, confirming service status of equipment, cleaning and monitoring processing rooms, gathering and preparing materials into cleanrooms.
Furthermore, during manufacturing activities inside the cleanrooms the post-holder is guiding the operators through aseptic production processes according to written procedures, ensuring that all steps are carried out correctly, passing materials between differently graded environments, completing necessary process tasks in the cleanroom and filling in the documentation in line with the Pharmaceutical Quality System (PQS).
For continuous improvements of processes, the Production Assistant is an active participant when investigations of deviations / quality exceptions are carried out and when corrective and preventive actions (CAPAs) are implemented.
In addition to be able to work independently strong team play with other members of the production team, including senior staff, is required by the Production Assistant to receive the required support and to master all tasks in a timely manner to the required standards. Close interactions with technical and quality staff of CGT-K is also needed on a regular basis to ensure milestones are met and products delivered according to schedule.
The Production Assistant must be highly motivated and interested in working in the GMP manufacturing field. Previous GMP experience is desirable, but at least basic GMP knowledge and biological background is crucial. Broad range of training on GMP is provided as required.
This post will be offered on an indefinite contract.
This is a full-time post.
- Support of GMP productions by:
- Following GMP procedures according to PQS
- Preparing batch-specific materials
- Ensuring equipment is ready for use
- Preparing and monitoring cleanrooms
- Guiding through manufacturing procedures
- Passing / manipulating materials during manufacturing processes
- Completing batch manufacturing records in real-time
- Participating in investigations and implementation of CAPAs
- Updating documents
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.
Skills, knowledge, and experience
- First degree in Biological Sciences or pharmaceutical background
- Knowledge in GMP
- Able to follow detailed written and verbal instructions
- Good attention to details
- Experienced in working in a multidisciplinary team
- Able to work independently without direct supervision
- Excellent organisational skills
- Able to priortise workloads in response to changing demands and requirements
- Experience in GMP / cleanroom operations
- Knowledge and experience in cell culture
- Able to draft well-written instructions
This post is subject to Disclosure and Barring Service and Occupational Health clearance.