Lead QC Scientist
Industry: Cell & Gene Therapy
Location: London, UK
Do you hold strong experience working with a variety of Biological Assays, working within the Quality testing of Biologics and supporting the development of Biological methods and processes? Do you hold experience working to GMP, and recognised as a Subject Matter Expert within your area of work?
SRG are currently working on an exclusive basis with a Cell & Gene Therapy company based in London. Experiencing continuous success resulting in current growth and also future growth, they are a forward thinking and people orientated company who put their employees, and patient first.
Due to continued success, we are currently seeking a Lead QC Scientist to join the London based QC team. Reporting to the Director of CMC Analytical Development and Quality Control, you will be seen as a Subject Matter Expert within QC method validation and testing.
- Develop Biological QC methods as required and implement required changes
- Participation in investigating or reviewing quality deviations, out of specifications and change controls.
- Write or review methods and develop method validation and qualification plans and strategies.
- Technical review of tech transfer documentation
- Interface with method development group to ensure delivery of documentation fit for purpose.
To be considered for this role you will have:
- Strong industry experience working within a QC environment.
- Industry experience using techniques for Biological testing of products (qPCR/ddPCR, immunoassays, cell-based assays, capillary electrophoresis)
- Experience within a GMP environment
- Strong awareness of a QMS within the QC environment (CAPA's, Out of Specifications)
- If candidates have worked specifically within Cell & Gene Therapy that would be beneficial.
This role would suit candidates with strong experience within QC Assays applied to Biological products, and additional areas such as developing methods and the associated documentation.
If this role is of interest please apply online or for more information contact Keith Mulgrew on 01223 607854.
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