Manufacturing Technician

University of Sheffield - School of Medicine & Population Health

Job description:

Overview

Reporting to the Head of Manufacturing, the Manufacturing Technician is a core part of Manufacturing operations at the Gene Therapy Innovation and Manufacturing Centre (GTIMC), performing routine manufacturing of medicines for Gene Therapies and rare diseases. The manufacturing team act as a CDMO for academic clients. The Manufacturing Technician will support the day to day running of the GMP cleanroom facility including cleaning, environmental monitoring, material transfer.

Led by Professor Mimoun Azzouz, The GTIMC at Sheffield is dedicated to advancing the clinical development of new genetic treatments options for millions of patients with life-threatening diseases. The centre will include a cutting-edge GMP (good manufacturing practice) facility that will support gene therapy projects emerging from universities across the UK, helping novel medicines progress to clinical trials. The facility will utilise highly efficient processes to manufacture clinical grade adeno-associated viruses (AAV) and provide all the necessary quality assurance and regulatory certification for human trials at NHS hospital sites.

Located at the University of Sheffield’s Innovation District, the GTIMC is close to the centres of Sheffield and Rotherham and within easy reach of major transportation corridors and regional shopping and entertainment complexes.

Main duties and responsibilities

• Perform routine manufacturing processes using aseptic technics to produce GMP batches for clinical applications of Gene Therapies.
• Support all technical, logistical and housekeeping aspects of GMP vector production and clean room operation at the GTIMC (Bioreactor operation, stock control, facility cleaning etc)
• Maintain quality production documentation within the GTIMC Quality Management System to GMP standards.
• Maintaining and calibrating equipment and instruments within the manufacturing clean rooms, ensuring all equipment remains operational within its validated parameters.
• Contribute to the development, writing and implementation of standard operating procedures for the GTIMC.
• Maintain the operational cleanliness of the clean rooms in line with GMP and GTIMC housekeeping procedures.
• Work as part of the wider GTIMC team, providing support as required to the other teams across the GTIMC facility as we work towards MHRA licensing.
• Carrying out investigations and root cause analysis of manufacturing exceptions and non-conformances.
• Support the continued improvement of GTIMC AAV production via implementation of process developments as directed by the Head of Production employing appropriate change control and risk assessment processes to ensure final product quality
• Participate in Technology Transfer activities within the GTIMC Quality Management System to GMP standards.
• Carry out other duties, commensurate with the grade and remit of the post.