Senior Quality Control Scientist

About the role:

The Senior QC Scientist will be responsible for the carrying out in-house quality control (QC) testing of cell and gene therapy products manufactured by the Cell and Gene Therapy (CGT) group as investigational medicinal products (IMPs) and as starting materials for further IMP manufacture. The role holder will ensure compliance of the QC testing with GLP, GMP and ICH guidelines as applicable. 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 lead on the development, validation and establishment of a broad range of start-of-the-art new in-house QC assays and work with external collaborators / clients on the tech transfer of QC assays into the CGT group. The maintenance of stability programs in conjunction with the Head of Quality and supervision of members of the QC team will also be undertaken by the role holder.

This is a full time post and you will be offered an indefinite contract.

About you: (the candidate)

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

Essential criteria

• Perform QC testing and stability of Final Product, drug substance and in-process samples to determine compliance with pre-defined specifications according to in-house procedures and Good Laboratory Practice / Good Manufacturing Practice (GMP) as applicable. Such testing will include but not be limited to flow cytometry-based assays, cell proliferation assay, protein assays and western blots and molecular techniques e.g. QPCR.
• Document testing and results in accordance with the Pharmaceutical Quality System (PQS) and apply the principles of data integrity. Review testing carried out by QC Scientists.
• Design and perform the validation of QC assays in accordance with ICH Q2, GLP and GMP guidelines and oversee the validation activities carried out by QC Scientist. Lead on the development of new QC assays and technology transfer of collaborator / client QC assays into the CGT group.
• Oversee in-coming raw material testing and batch testing of critical manufacturing materials e.g. serum, as per a defined programme, establish reference standards /materials where appropriate.
• Perform QC testing activities and stability testing in compliance with PQS and carryout duties in accordance with the PQS. Participate in internal and external audits. Initiate Out-of-Specification (OOS) and deviation reports / investigations for non-conformances associated with tasks in accordance with the PQS.
• Work as part of a multidisciplinary team with QA and Production to ensure QC testing carried out as required and to allow batch release times to be met. As required supervise members of the QC team such as QC Scientists. Support the process development of manufacturing processes with regards to establishment of in-process and QC testing programmes.

Desirable criteria

• Ability to write unambiguous comprehensive experimental protocols.
• Hands-on experience of microbiological environmental monitoring.
• Attend external meetings in relation to GLP compliance and development of QC assays for ATMPs by regulatory bodies/ industry leaders e.g. NIBSC/ Cell Therapy Catapult.
• Establish a system for the trending QC testing results and report in these to the Head of Quality and Head of Production on a Quarterly basis.
• Perform other tasks in relation to QC as required.

Closing date: 10 July 2024

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