The Cell and Gene Therapy, King’s (CGT-K) group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) and starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.
The Quality Control Scientist will be responsible for the carrying out in-house quality control (QC) testing of cell and gene therapy products manufactured by CGT-K group for clinical trials or as starting materials for use in the further manufacturing of ATMPs. Assays will include but not be limited to; flow cytometry-based assays, cell proliferation assays, protein assays and western blots and molecular based methods e.g., qPCR. The role holder will also support the development, validation and establishment of a broad range of state-of-the-art new in-house QC assays and will work with external collaborators on the technical transfer of QC assays into the CGT-K group. The QC Scientist will be responsible for maintaining an inventory of QC samples and will assist with the sending QC samples to external laboratories for testing and ensuring the testing results are received in a timely manner.
The role holder will also play a critical role in conducting immune monitoring studies as part of in-house early phase clinical trials of cell-based immunotherapies.
Testing of in-coming materials and participating in the routine environmental monitoring of the GMP facilities will also form part of the day-to-day activties of the role.
The work carried out by the QC Scientist must be undertaken in compliance with regulatory requirements and quality standards including those of ICH, ISO, GMP and Good Laboratory Practice.
The Quality Control Scientist will be an integral member of the QC team and work with team members across the whole of the Cell and Gene Therapy group including R&D, Production, Technical and Quality Assurance. The QC Scientist will be responsible to the Head of Quality.
This position provides an opportunity to develop a good understanding of a wide range of cell and gene therapy product analytical assays and QC testing within the medicines manufacturing field.
This is a full-time post, an indefinite contract.
- Perform QC and release testing of finished product and in-process samples to determine compliance with pre-defined specifications according to in-house procedures and Good Manufacturing Practice (GMP). Such testing will include but not limited to, flow-based assays, cell proliferation assay, protein assays and Western blots and cell counts.
- Carry out immune monitoring assays for in-house immunotherapy clinical trials.
- Carry out raw material testing and batch testing of critical manufacturing materials e.g., serum.
- Document testing and results in accordance with the Pharmaceutical Quality System (PQS) and GMP and apply the principles of data integrity at all times.
- Assist in the sending of QC samples including final products, in- process and growth promotion/media fill samples to external testing laboratories.
- Liaise with the external testing laboratories to ensure timely testing and receipt of results, file and verify results.
- Assist in stability studies, including in-house testing and sending samples for external testing.
- Draft and review QC Test Records, Standard Operation Procedures (SOPs) and other documentation associated with the QC testing of samples and stability studies.
- Participate in technology transfer activities for QC assays.
- Carry out the qualification and validation of QC assays.
- Assist in the development of new in-house QC assays.
- Order reagents, consumables and materials as required.
- Assist in the QC release of material for manufacturing and QC activities.
- Assist with the IQ/OQ/PQ and annual calibration / service of QC testing equipment as required.
- Carry out the reading of routine and sessional microbiological environment monitoring plates.
- Assist with routine microbiological environmental of the GMP facility as required.
- Initiate Out-Of-Specification (OOS) and deviation reports/investigations for non-conformances associated with tasks in accordance with the PQS at all times.
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
- Degree in one of the Biological Sciences or related discipline.
- Knowledge and understanding of a wide range of analytical assays including Enzyme-linked- Immunosorbent-Assay (ELISA), Protein Assays, Cell-based Flow Cytometry and qPCR.
- Demonstrated Quality Control (QC) experience (sample preparation, sample analysis/testing, data entry and review).
- On-hands laboratory-based experience of Flow Cytometry including use of flow cytometry analysis software packages.
- On-hands laboratory-based experience of qPCR including use of flow analysis software packages.
- Hands-on experience of mammalian cell culture.
- Ability to prioritise workloads in response to changing demands and requirements.
- Ability to follow detailed written standard operation procedures and verbal instructions.
- Able to take initiative and work without direct supervision.
- Good attention to detail.
- Experience of working to GMP or Good Laboratory Practice (GLP) in an academic setting biotechnology/pharmaceutical company or Hospital.
- Ability to write unambiguous comprehensive experimental protocols.
- Hands-on experience of microbiological environmental monitoring
This post is subject to Disclosure and Barring Service and Occupational Health clearance.