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 is a remarkable place to work. Our people are at the heart of everything we do. Their diverse backgrounds, abilities and beliefs make Sheffield a world-class university.

We offer a fantastic range of benefits including a highly competitive annual leave entitlement (with the ability to purchase more), a generous pension scheme, flexible working opportunities, a commitment to your development and wellbeing, a wide range of retail discounts, and much more. Find out more about our benefits (opens in a new window) and join us to become part of something special.

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.

Criteria

Essential or Desirable

Stage(s) assessed at

BSc (or equivalent) in a scientific field

• Essential Application
  Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.
• Essential Application
  Experience with aseptic practises
• Essential Application
  Working knowledge of GMP and the ability to apply standards as required for compliance in an advanced therapeutics manufacturing setting.
• Essential Application
  Attention to detail and a proven ability to keep accurate and reliable records.
• Essential Application/Interview/Test
  Good interpersonal, verbal and written communication skills.
• Essential Application/Interview/Test
  Comfortable in a fast-paced operational environment with minimal supervision.
• Essential Application/Interview/Test
  Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.
• Essential Application/ Test
  Good organisational and time management skills.
• Essential Application/ Test
  Experience of processing production techniques for AAV or Lenti vector systems, related cell culture and/or bioreactor systems and downstream techniques
• Desirable Application/Interview
  Report Writing Skills And Experience Of Delivering Presentations.
• Desirable Application
  Experience working within a Quality Management System (QMS).

Further Information

Grade: 5

Salary: £27,319

Work arrangement: Full-time

Duration: 3 years Fixed Term

Line manager: Toby Gamlen

Direct reports: Manufacturing Lead, Manufacturing technician

Right to work in the UK: 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.

Our website

https://www.sheffield.ac.uk/gtimc

Contact

For informal enquiries about this job contact Toby Gamlen, Head of Manufacturing: on [e-mail] 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 [e-mail]

Our vision and strategic plan

We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision (opens in new window).

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

More details can be found on our benefits page: sheffield.ac.uk/jobs/benefits (opens in a new window).

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.

We are a research university with a global reputation for excellence. Our ideas and expertise change the world for the better, making a real difference to society. We know that when people come together with different views, approaches and insights it can lead to richer, more creative and innovative teaching and research and the highest levels of student experience. Our University Vision (www.sheffield.ac.uk/vision) outlines our commitment to building a diverse community of staff and students that recognises and values the abilities, backgrounds, beliefs and ways of living for everyone.