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 facility that will support gene therapy projects 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.
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.
* 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.
* Carry 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.
Qualifications
* 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 practices.
* 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.
* 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).
Benefits
* 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 with access to learning and mentoring schemes; integrated with our Academic Career Pathways and Professional Services Shared Skills Framework.
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