The successful applicant will contribute to process optimisation, manage stock and shipments, and participate in departmental activities, ensuring adherence to UK MHRA GMP and GCP standards. The position also requires effective communication with stakeholders regarding project progress and milestones. Candidates seeking direct involvement in GMP production and clinical trials are encouraged to apply.
Applications are invited from experienced, flexible and motivated scientists, for a good manufacturing practice (GMP) lab technician role within the Cell and Gene Therapy Service (C>S) at Great Ormond Street Hospital NHS Foundation Trust. The C>S supports the manufacture of advanced therapy medicinal products (ATMPs) for the treatment of childhood diseases, as part of a research programme involving University College London, Great Ormond Street Institute of Child Health (UCL GOS ICH) and external collaborators.
The successful candidate will be trained to work in an aseptic manner to undertake ATMP production and conduct important assays required to monitor the efficacy and safety of therapies, in line with GMP regulatory requirements. The ideal candidate will have previous experience of cell culture and optimisation, such as a research assistant who would like more direct involvement with GMP manufacture and advanced therapy clinical trials. There is also considerable documentation involved in the preparation of each ATMP and as such, the applicant should be proficient with use of Microsoft Word and Microsoft Excel.
Please ensure that you read the attached job description and person specification carefully, as your application will be judged against these criteria.
For further information, or to arrange a visit, please contact Dr Annie Etuk via email: or by phone: 02ext. 38304.
- Contribute towards optimisation and validation of GMP manufacturing processes applicable to ATMP clinical trials.
- Participate in manufacturing of ATMP products for clinical trials
- Validate QC tests relevant to ATMP manufacture.
- Write and implement new BMRs, SOPs and worksheets.
- Accurately complete GMP documentation related to manufacturing, storage and shipment of ATMPs.
- To comply with UK MHRA GMP and GCP regulations applying to ATMP manufacturing and conduct of first-into-man clinical trials.
- To contribute to the overall normal activities of the research team and department as required, including laboratory duties and attendance at departmental meetings.
- To ensure that equipment used is safe and maintained in good working order.
- Manage stock: ordering and receipt of goods for manufacturing in compliance with GMP regulations; including critical starting materials such as viral vector and leukapheresis.
- Organise shipments to/from external laboratories and completion of relevant documentation.
- Participate in process simulations and media fills.
- Support in liaising with key stakeholders and client organisations to report on progress and delivery against project milestones.
About us
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience and knowledge required.
Please wait...this will take a moment...
