GMP Gene Therapy Manufacturing Technician

The University of Sheffield; Sheffield; On-site; GBP 25,000 - 30,000; Full time

Benefits offered by this job

38 days annual leave

Hybrid working

Generous pension

Staff discounts

Job summary

The University of Sheffield’s Gene Therapy Innovation and Manufacturing Centre (GTIMC) is seeking a Manufacturing Technician to support routine GMP manufacturing of clinical gene therapies. You will work in the GMP cleanroom, perform aseptic processing, maintain quality documentation and calibrate equipment to ensure compliance with regulatory standards.

Reporting to the Head of Manufacturing, you will contribute to SOP development and collaborate across multidisciplinary teams to support MHRA

Qualifications

• BSc (or equivalent) in a scientific field.
• Experience in gene therapy, biotechnology or related biological sciences.
• Experience with aseptic practices and GMP.
• Attention to detail with accurate record keeping.
• Good interpersonal, verbal and written communication skills.
• Able to work in a fast-paced environment with minimal supervision.
• Capable of working independently and in multidisciplinary teams to meet deadlines.
• Strong organisational and time management skills.
• Experience with production techniques for AAV or Lenti vector systems and related processes.
• Desirable: report writing and presentation delivery.
• Desirable: experience within a Quality Management System (QMS).

Responsibilities

• Perform routine GMP manufacturing processes for clinical gene therapies.
• Support cleanroom operations, including bioreactor operation, stock control and facility cleaning.
• Maintain GMP-compliant production documentation within the GTIMC Quality Management System.
• Calibrate and maintain equipment in the manufacturing clean rooms.
• Contribute to developing and implementing standard operating procedures.
• Maintain cleanroom cleanliness in line with GMP and GTIMC procedures.
• Collaborate with other teams to support MHRA licensing needs.
• Investigate manufacturing exceptions and perform root cause analyses.
• Assist process development and technology transfer under supervision.

Skills

Aseptic techniques

GMP compliance

Documentation

Team collaboration

Attention to detail

Independent working

Education

BSc (or equivalent) in a scientific field

Tools

Bioreactor operation

Job description

The University of Sheffield’s Gene Therapy Innovation and Manufacturing Centre (GTIMC) is seeking a Manufacturing Technician to support routine GMP manufacturing of clinical gene therapies. You will work in the GMP cleanroom, perform aseptic processing, maintain quality documentation and calibrate equipment to ensure compliance with regulatory standards.

Reporting to the Head of Manufacturing, you will contribute to SOP development and collaborate across multidisciplinary teams to support MHRA