Manufacturing Technician
| Dyddiad hysbysebu: | 08 Medi 2025 |
|---|---|
| Oriau: | Llawn Amser |
| Dyddiad cau: | 29 Medi 2025 |
| Lleoliad: | Sheffield, S9 1ZA |
| Cwmni: | University of Sheffield |
| Math o swydd: | Dros dro |
| Cyfeirnod swydd: | 1544-43638000 |
Crynodeb
University of Sheffield
Manufacturing Technician
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.
Further information
Grade: 5
Salary: £27,319
- £31,236 per annum. Potential to progress to £33,951 per annum through sustained exceptional contribution. Work arrangement: Full-time
Duration: Fixed Term Contract for 3 years.
Line Manager: Head of Manufacturing
Direct Reports: Head of Manufacturing
Our website: https://www.sheffield.ac.uk/gtimc
This role is laboratory based on site at the Gene Therapy Innovation and Manufacturing Centre GTIMC, Sheffield Business Park, S9 1ZA.
For informal enquiries about this job contact Toby Gamlen, Head of Manufacturing: on t.gamlen@sheffield.ac.uk
Person specification
Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.
Essential Critieria
- BSc (or equivalent) in a scientific field
- Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
- Experience with aseptic practises.
- Working knowledge of GMP and the ability to apply standards as required for compliance in an advanced therapeutics manufacturing setting.
- Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
- Attention to detail and a proven ability to keep accurate and reliable records.
- Good interpersonal, verbal and written communication skills.
- Comfortable in a fast-paced operational environment with minimal supervision.
- Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.
- Good organisational and time management skills.
Desirable Criteria
- Experience of processing production techniques for AAV or Lenti vector systems, related cell culture and/or bioreactor systems and downstream techniques
- Experience working within a Quality Management System (QMS).
Next steps in the recruitment process
It is anticipated that the selection process will take place on Wednesday 1st October. This will consist of an interview and a practical assessment. We plan to let candidates know if they have progressed to the selection stage on the week commencing 29th September. Contact Laura Haslam (l.haslam@sheffield.ac.uk) if you require any reasonable adjustments.
Our vision and strategic plan
We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision.
What we offer
- A minimum of 38 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
- Generous pension scheme.
- A wide range of discounts and rewards on shopping, eating out and travel.
- A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
- Recognition Awards to reward staff who go above and beyond in their role.
- A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways and Professional Services Shared Skills Framework.
Manufacturing Technician
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.
Further information
Grade: 5
Salary: £27,319
- £31,236 per annum. Potential to progress to £33,951 per annum through sustained exceptional contribution. Work arrangement: Full-time
Duration: Fixed Term Contract for 3 years.
Line Manager: Head of Manufacturing
Direct Reports: Head of Manufacturing
Our website: https://www.sheffield.ac.uk/gtimc
This role is laboratory based on site at the Gene Therapy Innovation and Manufacturing Centre GTIMC, Sheffield Business Park, S9 1ZA.
For informal enquiries about this job contact Toby Gamlen, Head of Manufacturing: on t.gamlen@sheffield.ac.uk
Person specification
Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.
Essential Critieria
- BSc (or equivalent) in a scientific field
- Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
- Experience with aseptic practises.
- Working knowledge of GMP and the ability to apply standards as required for compliance in an advanced therapeutics manufacturing setting.
- Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
- Attention to detail and a proven ability to keep accurate and reliable records.
- Good interpersonal, verbal and written communication skills.
- Comfortable in a fast-paced operational environment with minimal supervision.
- Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.
- Good organisational and time management skills.
Desirable Criteria
- Experience of processing production techniques for AAV or Lenti vector systems, related cell culture and/or bioreactor systems and downstream techniques
- Experience working within a Quality Management System (QMS).
Next steps in the recruitment process
It is anticipated that the selection process will take place on Wednesday 1st October. This will consist of an interview and a practical assessment. We plan to let candidates know if they have progressed to the selection stage on the week commencing 29th September. Contact Laura Haslam (l.haslam@sheffield.ac.uk) if you require any reasonable adjustments.
Our vision and strategic plan
We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision.
What we offer
- A minimum of 38 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
- Generous pension scheme.
- A wide range of discounts and rewards on shopping, eating out and travel.
- A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
- Recognition Awards to reward staff who go above and beyond in their role.
- A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways and Professional Services Shared Skills Framework.