King's College London
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 post holder will work as part of the CGT-K production team, manufacturing under GMP different types of Investigation Medicinal Products (IMPs) and “Specials” for cell therapies, but especially viral vectors for clinical trials. The post holder will be responsible for carrying out aseptic manufacturing processes in grade A environment, preparing productions including cleanrooms and equipment, and taking care of documentations in line with the Pharmaceutical Quality System (PQS) requirement.
We are looking for a highly motivated scientist who has excellent organisational skills, pays attention to details, and with experience in cell culture under GMP.
Production Scientists must be well familiar with different production protocols to be able to manufacture a diverse range of cell and gene therapy products under GMP meeting required quality standards. Production Scientists take care of the preparation of production campaigns including documentation, materials, equipment, and facility. To be able to carry out any manufacturing activities Production Scientists are responsible to keep themselves, processes, and equipment qualified. As qualified GMP operators Production Scientists perform production processes in GMP cleanrooms, especially grade A environment. Furthermore, constantly good documentation practice is required. For the completion of tasks in charge of Production Scientists must be able to work independently, but also in small teams when carrying out production activities. Production Scientists are responsible for batch-specific documentation, troubleshooting / investigations and coming up with CAPAs as well as implement those. Writing and reviewing of GMP documents like SOPs is an additional area Production Scientists are working at to ensure successful production activities of CGT-K.
This post will be offered on an indefinite contract
This is a full-time post
• Manufacture of different types of products under GMP
• Preparation of production campaigns
• GMP documentation
• Qualification of processes, staff, equipment, facilities
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.
1. Experience in working under GMP in cleanroom environment
2. First degree in Biological Sciences or related discipline
3. Knowledge and experience in working aseptically
4. Knowledge of cleanroom operations
5. Ability to follow detailed written SOPs and verbal instructions
6. Ability to prioritize workload in response to changing demands and requirements
10. Ability to work both independently and in a team
1. Experience with cell culture and/or viral vector manufacture
2. Knowledge of GMP regulations
3. Experience in drafting documents
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