Senior Quality Control Scientist

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About us:

The King's College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer and training to address critical skills shortages.

In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.

The GTVF is run by a large, industry-leading team of >50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic and commercial clients, with a focus on early-stage clinical trials.

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.

Working as part of a multidisciplinary team (quality assurance, production, process development) the Senior Quality Scientist will support the process development of manufacturing processes with regards to establishment of in-process and QC testing programmes.

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

1. 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
2. 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
3. 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 in to the CGT group.
4. 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
5. 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.
6. 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

1. Ability to write unambiguous comprehensive experimental protocols.
2. Hands-on experience of microbiological environmental monitoring
3. 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
4. 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.
5. Perform other tasks in relation to QC as required.

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click "Apply Now". This document will provide information of what criteria will be assessed at each stage of the recruitment process.

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's. We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the advert. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.

To find out how our managers will review your application, please take a look at our 'How we Recruit' pages.