My client, based in Stevenage, are specialists in helping Cell and Gene therapy companies translate early stage research into quality, commercially viable, scalable and investable therapies.
With a team of over 120 Cell and Gene therapy experts and state-of-the-art development and viral vector labs, my client has ensured they remain a Centre of Excellence in this field.
The Qualified Person (QP) will participate in the translation of strategic direction into a Quality framework that defines, directs and governs the tactical application of GMP compliance for the Manufacturing Centre. In the first instance, this will be predominantly focused on developing and supporting the delivery of a fit for purpose Quality Management System and providing practical quality subject matter expertise to both CGT and collaborating residents (“Collaborators”). This activity will be required to support the initial grant of the facility MIA and MIA(IMP), and then to support on-going operations.
The Manufacturing Centre hosts Collaborator manufacturing activities. You will perform batch certification for Collaborator manufacturing activities, as required, and act as a QP for the Manufacturing Centre.
• Direct report to the Head of QA with close interaction with the Manufacturing Centre Management Team
• Provide subject matter expertise in quality assurance, aseptic manufacturing and environmental microbiology to Manufacturing Centre staff and Collaborators
• Ideally, act as Site Microbiologist, otherwise provide expert advice on Annex 1 requirements by approving the facility environmental monitoring, gowning and cleaning regimes.
• Provide expert advice for microbiology changes and deviations and coach QC staff on microbiology as required (note: line management of the microbiology laboratories is not a part of this job specification)
• Ensure the QMS is fit for purpose for a multi-purpose, multi-client facility, and maintain processes to ensure site compliance to the QMS
• Maintain processes for batch certification for Collaborators and perform batch certification of ATMPs and or ATIMPs for Collaborators
• Perform QP approval of Manufacturing Centre data (e.g. environmental monitoring data) to support certification by Collaborator QPs, Product Quality Reviews etc.
• Develop and maintain QP to QP Agreements, as required, with Collaborator QPs
• Represent the Manufacturing Centre as a QP, to external regulators, inspectors and Collaborators
• Participate in the preparation and management of regulatory agency and client inspections, including co-hosting as required.
Salary is negotiable on experience
For more information and a confidential discussion, please contact Kieran Whittaker on the below: -
Tel: 0161 923 8174