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 acts 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 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 (Bioreactor operation, stock control, facility cleaning etc)
- 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.
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.
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.
Attention to detail and a proven ability to keep accurate and reliable records.
Application/Interview/Test
Good interpersonal, verbal and written communication skills.
Application/Interview/Test
Comfortable in a fast-paced operational environment with minimal supervision.
Application/Interview/Test
Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.
Good organisational and time management skills.
Experience of processing production techniques for AAV or Lenti vector systems, related cell culture and/or bioreactor systems and downstream techniques
Report writing skills and experience of delivering presentations.
Experience working within a Quality Management System (QMS).
Further Information
Manufacturing Lead, Manufacturing technician
This role does not meet the criteria for Skilled Worker sponsorship under the UK Visa & Immigration points-based system. Information on alternative visa options is available on www.gov.uk.
If you do not currently hold the right to work in the UK, you can find more information here to help determine your visa eligibility. Additional guidance is also available on the UK Visa & Immigration website.
https://www.sheffield.ac.uk/gtimc
For informal enquiries about this job contact Toby Gamlen, Head of Manufacturing: on t.gamlen@sheffield.ac.uk or on 0114 2220652.
Next steps in the recruitment process
It is anticipated that the selection process will take place w/c 21st September. This will consist of an interview, a test and a presentation. We plan to let candidates know if they have progressed to the selection stage on the week commencing 14th September. If you need any support, equipment or adjustments to enable you to participate in any element of the recruitment process you can contact Toby Gamlen [email protected]
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.
- Flexible working opportunities, including hybrid working for some roles.
- 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; Professional Services Shared Skills Framework.
- A range of generous family-friendly policies
- paid time off for parenting and caring emergencies
- access to menopause support in the workplace
- paid time off and support for fertility treatment
- and more
We are a Disability Confident Leader (opens in a new window). If you have a disability and meet the essential criteria for this job you will be invited to take part in the next stage of the selection process.
