Quality Control Scientist

About the role

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. 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.

This is a full time post (35 hours per week), and you will be offered an indefinite contract.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• 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, qPCR, mammalian cell culture
• Ability to prioritise workloads in response to changing demands and requirements. Able to take initiative and work without direct supervision
• Experience of working to GMP or Good Laboratory Practice (GLP) in an academic setting biotechnology/pharmaceutical company or Hospital
• Ability to follow detailed written standard operation procedures and verbal instructions. Good attention to detail

Desirable criteria

• Ability to write unambiguous comprehensive experimental protocols
• Hands-on experience of microbiological environmental monitoring 

Closing date: 07 July 2024

Advert information