Manufacturing Technician

Diversity Dashboard; Sheffield; On-site; GBP 25,000 - 30,000; Full time

Benefits offered by this job

38 days annual leave

Flexible working

Generous pension

Staff discounts

Professional development

Family-friendly policies

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 gene therapy products. You will work in a cleanroom environment, perform aseptic operations, maintain equipment and documentation, and contribute to quality systems.

This full-time, fixed-term role offers a Grade 5 salary with generous benefits and hybrid working arrangements.

Qualifications

• BSc (or equivalent) in a scientific field is essential.
• Experience in gene therapy, biotechnology or related biological sciences.
• Experience with aseptic techniques and GMP environments.
• Good documentation and record-keeping skills within a QA/QMS.
• Strong communication and ability to work in a multidisciplinary team.
• Ability to work with minimal supervision in a fast-paced setting.

Responsibilities

• Perform routine GMP manufacturing processes for gene therapy products in a cleanroom.
• Support vector production, facility cleaning, stock control and related GMP activities.
• Maintain quality production documentation within the QMS to GMP standards.
• Calibrate and maintain equipment to keep operations within validated parameters.
• Develop and implement standard operating procedures and assist in technology transfer.

Skills

Aseptic practices

GMP knowledge

Attention to detail

Record keeping

Interpersonal communication

Time management

Teamwork

Education

BSc (or equivalent) in a scientific field

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 pensions 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.

Further Information

Criteria: BSc (or equivalent) in a scientific field

Essential or desirable: Essential

Stage(s) assessed at: Application

Criteria: Relevant work experience in and manufacturing capacity within gene therapy, biotechnology or other biological sciences.

Essential or desirable: Essential

Stage(s) assessed at: Application

Criteria: Experience with aseptic practises

Essential or desirable: Essential

Stage(s) assessed at: Application

Criteria: Working knowledge of GMP and the ability to apply standards as required for compliance in an advanced therapeutics manufacturing setting.

Essential or desirable: Essential

Stage(s) assessed at: Application

Criteria: Attention to detail and a proven ability to keep accurate and reliable records.

Essential or desirable: Essential

Stage(s) assessed at: Application/Interview/Test

Criteria: Good interpersonal, verbal and written communication skills.

Essential or desirable: Essential

Stage(s) assessed at: Application/Interview/Test

Criteria: Comfortable in a fast-paced operational environment with minimal supervision.

Essential or desirable: Essential

Stage(s) assessed at: Application/Interview/Test

Criteria: Ability to work independently as well as part of a multidisciplinary team to meet tight deadlines.

Essential or desirable: Essential

Stage(s) assessed at: Application/ Test

Criteria: Good organisational and time management skills.

Essential or desirable: Essential

Stage(s) assessed at: Application/ Test

Criteria: Experience of processing production techniques for AAV or Lenti vector systems, related cell culture and/or bioreactor systems and downstream techniques

Essential or desirable: Desirable

Stage(s) assessed at: Application/Interview

Criteria: Report writing skills and experience of delivering presentations.

Essential or desirable: Desirable

Stage(s) assessed at: Application

Criteria: Experience working within a Quality Management System (QMS).

Essential or desirable: Desirable

Stage(s) assessed at: Application

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

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 38days 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.