Senior QC Scientist, Biopharmaceuticals - Hertfordshire
Jason Johal is recruiting for an experienced Senior QC Scientist to join a biopharmaceutical company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a permanent role based in Hertfordshire and offers an excellent salary between £30,000 - £40,000 and a good benefits package.
Our client is fast progressing simultaneously several programmes towards clinical investigation and is now establishing a new Discovery Laboratory to ensure the rapid translation of their innovative vectors into clinic benefit. The research group places a strong emphasis on innovation, ability to make a difference to the patients, as well as the ability to apply your skills and develop new ones by collaborating with a multidisciplinary team. They will provide you with promising and exiting research projects in an environment that strongly values your development.
They are building a team to drive their portfolio forwards and are seeking a Senior QC Scientist to report to the Director Quality Control and, in collaboration with the senior CMC scientific team and Quality Assurance be responsible for management of QC analytical strategies, growing and developing the internal QC regulated laboratory skill base with a focus on quality and GMP compliance, plus assist with selection and management of external contracted partner laboratories. The successful candidate will play a key operational role in securing successful delivery of the company's CMC development programmes, building internal QC capability, and ensuring compliant release testing of GMP batches at both CMOs and internally. Other duties will include the management of analytical method transfer, development and validation at and between partner contract research organisations, developing and maintaining systems for specification approval, CofA issuance, stability testing and analytical trending.Your Background
We are seeking individuals with a degree and experience in the Analytical Sciences relevant to Quality Control of Biotechnology/Biopharmaceuticals/Vaccines gained in industry and within a Quality Management System. A current awareness and demonstrable experience in Good Manufacturing Practice Quality control testing regulatory compliance (MHRA GMP Guidelines, Eudralex vol. 4, QC Annexes) along with a demonstrable knowledge of the documentation requirements for GMP Quality Control including maintenance of data integrity, computer systems validation, equipment procurement and qualification are also required. Experience of working in pharmaceutical field with a regulated testing focus and of working in collaboration with Quality Assurance professionals, including supplier audits and in house auditing programs including environmental monitoring is required as is significant experience in Physicochemical, Biochemical, and Biological assays in a variety of applications. Experience of a wide range of analytical techniques and expertise in analytical development along with experience of analytical process science, and/or formulation science for viral gene therapy products would be preferred and any experience of early stage clinical development would be ideal.
If successful you will be joining a rapidly growing world-class multidisciplinary team and will have the rare opportunity not only to engage in laboratory science but also influence the shape and direction of this exciting new biotechnology venture.
For more information or to apply for this Senior QC Scientist position, please contact Jason Johal on 01438 723 500 or email@example.com. Alternatively, please click on the link below to apply online now. 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 ST42584 in all correspondence.