GMP Gene Therapy Manufacturing Technician

Dunhillmedical; Sheffield; Hybrid; GBP 25,000 - 30,000; Full time

Benefits offered by this job

Annual leave

Pension

Flexible working

Discounts

Development opportunities

Job summary

University of Sheffield is seeking a Manufacturing Technician to join the Gene Therapy Innovation and Manufacturing Centre (GTIMC) in Sheffield. You will support routine GMP manufacturing of gene therapy products and assist with cleanroom operations, documentation and quality systems.

The role requires a BSc in a scientific field, experience in aseptic GMP settings, and the ability to work in a fast-paced, team-based environment.

Qualifications

• BSc (or equivalent) in a scientific field.
• Relevant manufacturing experience in gene therapy or biotech.
• Experience with aseptic practices.
• Knowledge of GMP and regulatory standards.
• Strong record-keeping and documentation.
• Good communication and teamwork.

Responsibilities

• Perform routine manufacturing processes using aseptic techniques 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.
• Maintain quality production documentation within the GTIMC Quality Management System to GMP standards.
• Maintain and calibrate 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.
• To maintain the operational cleanliness of the clean rooms in line with GMP and GTIMC housekeeping procedures.
• To 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.

Skills

GMP manufacturing

Aseptic technique

Quality Management System

Documentation

Team collaboration

Education

BSc in science

Tools

Bioreactor operation

Analytical equipment

Job description

University of Sheffield is seeking a Manufacturing Technician to join the Gene Therapy Innovation and Manufacturing Centre (GTIMC) in Sheffield. You will support routine GMP manufacturing of gene therapy products and assist with cleanroom operations, documentation and quality systems.

The role requires a BSc in a scientific field, experience in aseptic GMP settings, and the ability to work in a fast-paced, team-based environment.