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Job Opportunity: Quality Control Scientist:Job description:Job location: London Job description 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 located 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-located assays, cell proliferation assays, protein assays and western blots and molecular located methods e.g., qPCR. The function 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 function holder will also play a critical function in conducting immune monitoring studies as part of in-house early phase clinical trials of cell-located 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 function. 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 knowledge of a wide variety of cell and gene therapy product analytical assays and QC testing within the medicines manufacturing field. This post will be offered on an indefinite contract. This is a full-time 100% full time equivalent. expertise, knowledge, and practice Essential criteria » Degree in one of the Biological Sciences or related discipline. » Knowledge and knowledge of a wide variety of analytical assays including Enzyme-linked- Immunosorbent-Assay (ELISA), Protein Assays, Cell-located Flow Cytometry and qPCR. » Demonstrated Quality Control (QC) practice (sample preparation, sample analysis/testing, data entry and review). » On-hands laboratory-located practice of Flow Cytometry including use of flow cytometry analysis software packages. » On-hands laboratory-located practice of qPCR including use of flow analysis software packages. » Hands-on practice of mammalian cell culture. » capability to prioritise workloads in response to changing demands and requirements. » capability to follow detailed written standard operation procedures and verbal instructions. » Able to take initiative and work without direct supervision. » Good attention to detail. Desirable criteria » practice of working to GMP or Good Laboratory Practice (GLP) in an academic setting biotechnology/pharmaceutical company or Hospital. » capability to write unambiguous comprehensive experimental protocols. » Hands-on practice of microbiological environmental monitoring Closing date: 10 April 2024 Skills:
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