A cutting-edge biotech based in Stevenage are recruiting for a Quality Control Specialist who has strong quality and analytical expertise (e.g. flow cytometry, assay development / validation) to join their expanding team at this state of the art centre. The company are a leading the way in the commercialisation of life changing cell & gene therapies, taking these through the commercialisation process using their expertise and cutting-edge services.
The Quality Control Specialist is a broad and influential position where you will have influence in the running of QC operation to ensure compliance to GMP and the delivery of service with high standards. With the responsibility for the new center meets the expectations of collaborators and is in compliance to GMP.
The role of QC Specialist oversees the day to day running of the laboratory support team (e.g. environmental monitoring), sample & LIMS management, Microbiology to ensure all functions are running to a high standard and in compliance to GMP. Working on a range of projects in close partnership with collaborators who are running manufacturing operations from the facility that operates on a multioccupancy basis.
This role requires you to be flexible to execute the project requirements and reporting so that the QC provisions is in line with each collaborator’s requirements. Working closely with them to stablish what is required and achievable to align with their own aims. As the Specialist, you will lead the tech transfer validation and execution of routine analytical techniques in the laboratories. With flow cytometry, PCR, and ELISA being the most commonly used. As the Specialist, you will also lead service improvements to ensure the service provided is the best it can be, suggest new ideas, and use your expertise in a visible manner.
Desired Skills and Experience:
You will need to have GMP Quality Control experience in the Biologics / Biopharmaceutical / Aseptic /Cell & Gene Therapy sectors with experience of assay development and validation. As well as experience of techniques used such as flow cytometry and ELISA. You will need to have strong leadership experience as well with the ability to lead projects and work with external stakeholders.
The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialisation of these fast developing, cutting edge technologies. They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services. This currently consists of 12 (of which 6 very recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.