Senior GMP Quality Control Technician

Job description

Role Purpose

The Ocular Cell and Gene Therapy group (OCGT), in the Centre for Gene Therapy and Regenerative Medicine (CGTRM), develops a wide variety of novel cell and gene therapies for the treatment of neurodegenerative diseases, with a particular emphasis on retinal disease.

This is an exciting opportunity to work at the interface of basic and clinical research in a group that is at the forefront of developing novel therapies for retinal disorders, with a major emphasis on translating research into clinical application. Led by Professors Robin Ali and Rachael Pearson (previously at UCL’s Institute of Ophthalmology), it is one of the largest cellular therapy groups in the country and is currently expanding. Over the past 20 years, the group has been optimising cell transplantation to the eye to develop novel therapeutic approaches for eye disease and in particular for disorders affecting the retina, including inherited retinal degeneration. The programme has already led to first-in-human clinical trials of gene and cell therapy for eye disease and we are now in the pre-clinical development phase for clinical trials for photoreceptor cell therapy.

This role is for a qualified and trained GMP Quality Control Technician who has been working in the Quality Control department related to analytical development, validation, testing and release of cell-based products as IMPs in an academic or industry-led GMP manufacturing facility. The work will include day-to-day execution of QC testing operations, ensuring the schedule is followed by participating in QC assay development, validation, testing and release processes, liaising with the quality and technical teams, preparing of GMP compliant documentation, identifying bottlenecks and reporting to the Production Manager and Academic leads. In fulfilling these tasks, a strong background in cGMP, analytical testing/validation and good interpersonal skills will be essential, but training (both in-house and through external courses) will be provided, as deemed necessary.

Role profile

As part of the role profile, the GMP Quality Control Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, process/QC validation activities leading to site readiness and GMP inspection of the cell therapy manufacturing facility including implementation of electronic quality system and batch record documentation and be trained in the manufacturing and release of cell therapy products. Further, the post holder may be required to support other projects within the OCGT group and will design and execute experiments independently or in collaboration with other group members, as required by managers.

The postholder will have sufficient expertise working in a GMP licensed facility and be competent in molecular, cellular and analytical techniques, QC development, validation of quality control assays for in-process, stability and release testing including processing of samples for Crude Bulk Harvest, Drug Substance & Drug Product, including stability testing. They will have experience in ensuring compliance to pharmaceutical quality system, interacting with quality assurance, compiling laboratory reports and ensuring QC testing as per product specification file, reviewing electronic quality records for quality approval, batch certification and QP release. They will be trained in and have experience of performing assigned duties within a team and interacting with QC staff performing analytical testing (QC assay development and validation) operations, for process/analytical assay optimisation and development, validation, manufacturing, QC testing and release of products for clinical trials.