Senior GMP Production 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.

Role profile

As part of the role profile, the GMP Production Technician will be required to participate in initial site start-up activities related to facility and equipment qualification, process validation activities leading to site readiness and GMP inspection of the stem 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.

The work will include day-to-day operations and execution of GMP development and production runs, ensuring the schedule is followed by participating in development, validation and manufacturing processes, liaising with the quality and technical team, preparing GMP compliant batch documentation, identifying bottlenecks and reporting to the Production Manager.

Further, the post holder may be required to take an active role in other projects within the Ocular Cell and Gene Therapy Group, as required by manager or head.

The postholder will have expertise working in a GMP licensed facility and be trained in aseptic techniques and stem cell culture techniques, process development, validation of process for GMP batch manufacturing. They will have been trained in ensuring compliance to pharmaceutical quality system (PQS), interacting with quality assurance, compiling laboratory reports and product specification file, executing electronic batch manufacturing records leading to approval, batch certification and QP release. They will be experienced in performing assigned duties within a team and interacting with Production staff performing upstream processing (thawing to crude bulk harvest) and downstream processing (bulk purification to final vialed product) operations, after completion of process optimisation and development, and process validation for GMP batch manufacturing and release of products for clinical trials.

Further training will be provided, as deemed necessary.

This is a unique opportunity to work in a vibrant translational research environment bridging. The post holder will work in a collaborative team environment with very high potential to learn new skills.

This post will be offered on a fixed-term contract for 24  months in the first instance

This is a full-time post - 100% full time equivalent