• Job Description

  Req#: 2541

  Position Details

  Advanced Therapies Facility, College of Medical and Dental Sciences

  Location: University of Birmingham, Edgbaston, Birmingham UK

  Full time starting salary is normally in the range £29,762 to £32,411 with potential progression once in post to £36,333

  Grade 6

  Full Time, Fixed Term contract up to July 2026

  Closing date: 1st October 2023
  
  
  Our offer to you

  People are at the heart of what we are and do.

  The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success.

  We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University.

  We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work.

  Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries.

  The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens.

  Find out more about the benefits of working for the University of Birmingham

  Background

  The University of Birmingham is a global institution working within a diverse and vibrant City, offering an inspiring education to our students, and undertaking critically important research. We are a place of open, critical thinking, and the creation, sharing and dissemination of knowledge. Professional Services put students at the heart of all they do and enable an exceptional educational experience. They provide outstanding support to our researchers and help the University to grow its influence regionally, nationally, and globally. They ensure the University’s resources are used wisely, manage and improve the infrastructure which sits at the heart of the institution, and support decisions to be made quickly and based on sound evidence. Our Birmingham Professional programme operates across the University, supporting colleagues to network and collaborate, offering opportunities to learn and develop, contributing to the delivery of the University’s objectives, and helping everyone to understand the broader context within which we work.

  Role summary

  This post is based within the Medicines Manufacturing Facility (MMF), which encompasses the Good Manufacturing Practice (GMP) compliant Cell Therapy Suite (CTS), Microbiome Treatment Centre (MTC) and the manufacturing component on the Healthcare Technologies Institute (HTI). The MMF is a key facility helping to deliver high quality clinical and translational research programmes that are central to the College of Medical and Dental Sciences’ and Birmingham Health Partners’ research strategies, as well as to researchers within academia, the NHS and industry throughout the UK and internationally.

  The CTS is currently producing cell-based therapies for clinical trials, is licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) (MIA(IMP) Investigational Medicinal Product) and Human Tissue Authority (HTA – application licence) and works to GMP compliant standards. The MTC is the first MHRA licensed facility in the UK to provide Faecal Microbiota Transplant (FMT) for clinical trials and for the treatment of patients with recurrent and refractory Clostridioides difficile infection (CDI).

  The MMF is expected to comply with MHRA and HTA regulations as appropriate, as well as all other relevant legislative and clinical-, research- and information-governance arrangements. It is therefore a requirement that procedures are carried out according to strict Standard Operating Procedures set out in a robust and integrated Pharmaceutical Quality System.

  The Quality Support Officer role is a role within the MMF, and reports to the Quality Manager.

  This post is required to support both the Quality Control (QC) Manager, responsible for ensuring that the activities associated with the manufacture and QC of therapies produced within the CTS and MTC are carried out in a manner compliant with Good Manufacturing Practice (GMP) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The role will also have involvement in the development, transfer and validation of new quality testing protocols when new projects arise.

  Main duties

  • Duties must be carried out in accordance with all applicable regulatory, legislative and quality standards.
  • Collation of data for trending, technology transfer and process validation associated with new projects.
  • QC analysis of samples collected in process to monitor factors which may affect product quality, final product and sterility testing. Development of validated analytical assays associated with new projects.
  • Approval and monitoring of suppliers, goods receipt, the designation and monitoring of storage areas/units for materials and products.
  • Installation and validation of new equipment, maintenance, calibration and cleaning.
  • Development and strict implementation of written procedures and documents forming part of the MMF Quality Management System, training of technical staff on new developments, and contribution to internal/external audits and regulatory inspections (including corrective and preventative actions).
  • Assisting the QC manager with the Identification of assessment, root actions, non-conformances related to manufacture or QC, risk cause analysis, implementation of corrective and preventative
  • Assisting the QC manager with the Instigation and implementation of the appropriate procedures for controlling changes related to manufacture or QC within the CTS related to manufacture or QC.
  • Completion, maintenance and appropriate management of all records associated with the quality related duties carried out and ensuring appropriate review and sign off.
  • Assisting in the implementation of laboratory Health & Safety.
  • Any other duties commensurate with the grade and skill base of the post holder as directed by the Line Manager.
  • Promotes equality and values diversity, acting as a role model and fostering an inclusive working culture.
  • Supports the University’s sustainability agenda through resource efficient working.

  Person Specification

  • BSc (or equivalent), in a life or biological science, or biomedical science.
  • Sound knowledge and proficient experience of in vitro aseptic human tissue processing and cell culture, and cell-based phenotypic and functional analyses.
  • Knowledge of the legal and regulatory framework which governs the production of cell- and tissue-based therapies for human application.
  • Experience of working within a regulated laboratory environment and within a formal Quality Management System.
  • Familiar with the health and safety requirements relating to biological samples and microbiological safety.
  • Ability to manage time independently and effectively, prioritise when there are conflicting demands and pressures, and work to deadlines.
  • Good Interpersonal and communication skills, and ability to work effectively as part of a team.
  • Based on experience, the ability to anticipate and identify problems, and suggest solutions.
  • A critical and intelligent attention to detail and high standards of accuracy; ability to keep accurate records.
  • Good level of knowledge and experience of computer packages including MS Word, Excel, PowerPoint, and statistical packages. Word processing and document layout skills.
  • Technical aptitude, and a commitment to learn and readily master new techniques and skills.
  • An understanding and interest in the therapeutic potential, opportunities and challenges of using cell- and tissue-based therapies.

  OH & DBS required

  Pre-employment OH & DBS

  The University is committed to safeguarding and we promote safe recruitment practice, therefore all associated pre-employment checks will be undertaken before any appointment is confirmed. Due to the nature of the work undertaken in this role all successful applicants will be subject to a satisfactory Occupational Health and DBS clearance prior to appointment.

  Further particulars can be found here

  Informal enquires to Renu Varma, email: R.Varma@bham.ac.uk

  View our staff values and behaviours here

  Valuing excellence, sustaining investment

  We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working .

• About the company

  The University of Birmingham is a public research university located in Edgbaston, Birmingham, United Kingdom.

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