Jason Johal is recruiting for an experienced Quality Control and Bioanalytical Scientist to join a privately-held clinical-stage biotechnology company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. As part of building capability to drive their portfolio forwards, you will join a rapidly growing world-class multidisciplinary team and engage in laboratory science at this exciting new biotechnology venture. This is a permanent role based a short 20-minute train journey north of London in Hertfordshire and offers an excellent salary up to £40,000 plus a good benefits package.
Our client is fast progressing simultaneously several programmes towards clinical investigation and is focused on the rapid translation of their innovative vectors into clinic benefit. The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe and places a strong emphasis on innovation and the ability to make a difference to the patients. Their gene therapy treatment builds upon their own pioneering work and their proprietary AAV capsid which is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein. With sites in the UK, Germany and the US and an aggressive business plan it is an ideal time to joing this patient focused company.
You will support the QC manager in establishing a GMP/GCLP compliant QC laboratory to support the release and stability testing of AAV products manufactured at their GMP facility. You will be involved in testing pre and post clinical samples as part of our clinical trial programmes and the technology transfer and validation of in-process and release assays from the Development lab which is based in Gernay into the new QC lab in Hertfordshire. You will be expected to support the GMP manufacturing team with envoriomental monitoring and raw material release and whilst following SOPs and Protocols and will conduct routine maintenance, verification and qualification of specified analytical systems to include PCR and plate reader systems. You will also contribute to analytical methods development and participate in training and development programs.
Further duties will include presenting data at Project Team meetings, participating in analytical and OOS investigations, within a culture of continuous improvement and notifying unusual observations, errors/unexpected findings to management. A key aspect of the role will be maintain a close working relationship with the development lab Germany.
You will hold a degree (or equivalent) and experience in the Analytical Sciences gained during the development of Biotechnology/Biopharmaceuticals/Vaccines either in industry and/or reserch. You will have significant experience in Biological assays in a variety of applications to include establishing and validating RT-PCR methods and Cell based assays.
With experience of aspetic cell culture techniques, working in a GMP/GCP environment and working wih quality professionals you will contribute to the reporting of data, generation of certificates, protocols, SOPs and internal written reports. Experience of working within a QMS to include change control systems, deviations and OOS reporting is expected as is experience of analytical testing in a regulated environment. Understanding of a GMP manufacturing environment is required and experience of GxP documentation requirements for Quality Control and bioanalysis, with an emphasis on data integrity, sample traceability and ensuring confidentiality at all times would be preferred.
An understanding of the elements of risk management to help lead on decisions, expertise in analytical development, experience of analytical process science, and/or formulation science for viral gene therapy products and experience of pre-clinical and early stage clinical development are all advatangous.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44960 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Jason Johal
- Phone: 01438 723 500
- Reference: 44960
- Posted: 11th March 2019
- Expires: 8th April 2019