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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, and material transfer.
The GTIMC is dedicated to advancing clinical development of new genetic treatments. The centre will include a GMP facility that will support gene therapy projects from universities across the UK, manufacturing clinical grade AAV and providing QA and regulatory certification for human trials at NHS hospital sites.
Location: Gene Therapy Innovation and Manufacturing Centre (GTIMC), Sheffield Business Park, S9 1ZA.
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.
* Maintain the operational cleanliness of the clean rooms in line with GMP and GTIMC housekeeping procedures.
* Collaborate with the wider GTIMC team, providing support to other teams as we work towards MHRA licensing.
* Carry out investigations and root cause analysis of manufacturing exceptions and non-conformances.
* Support continuous improvement of GTIMC AAV production through process developments with appropriate change control and risk assessment.
* 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 (qualifications and experience)
* BSc (or equivalent) in a scientific field.
* Relevant work experience in manufacturing capacity within gene therapy, biotechnology or other biological sciences.
* Experience with aseptic practices.
* Working knowledge of GMP and ability to apply standards in an advanced therapeutics manufacturing setting.
* Attention to detail and ability to keep accurate records.
* Good interpersonal, verbal and written communication skills.
* Comfortable in a fast-paced operational environment with minimal supervision.
* Ability to work independently and as part of a multidisciplinary team to meet tight deadlines.
* Good organisational and time management skills.
* Experience with 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, consisting of an interview and a practical assessment. We plan to inform candidates if they have progressed to the selection stage during the week commencing 29th September. For reasonable adjustments, contact Laura Haslam (l.haslam@sheffield.ac.uk).
What We Offer
* Salary: £27,319 - £31,236 per annum. Potential progression to £33,951 per annum through sustained exceptional contribution.
* Work arrangement: Full-time
* Duration: Fixed Term Contract for 3 years.
* Benefits include generous annual leave, pension scheme, flexible working opportunities, development and wellbeing programs, discounts, and more.
Grade: 5. Line Manager: Head of Manufacturing. Direct Reports: Head of Manufacturing.
Our website: https://www.sheffield.ac.uk/gtimc
Contact emails for informal enquiries: t.gamlen@sheffield.ac.uk and l.haslam@sheffield.ac.uk.
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