A clinical stage Biopharmaceutical company who are developing pioneering T Cell therapies for the treatment of cancer are seeking a Principal QC Scientist to join their expanding GMP operations based in Stevenage, Hertfordshire. They are manufacturing therapies for use in Phase I and II clinical trials with these progressing to their respective latter stages soon. They are therefore recruiting additional expertise into the team for an SME in QC test methods and supporting clinical trial manufacturing.
This is a permanent role in Stevenage, paying a salary up to £50,000 plus benefits 9including bonus and healthcare). You will work 9am to 5pm, Monday to Friday. This is a fantastic career opportunity for an ambitious scientist who is passionate about undertaking a senior role within a pioneering cell therapy company.
As a Principal QC Scientist, you will be an SME in the Quality Control department to support the delivery of high-quality T-Cell products for trials. This is an expanding operation, meaning you will have the chance to contribute to the strategy and develop your career in the longer term as part of a high performing team.
Your responsibilities will include:
- Operating as an SME for cross functional projects and for QC test methods and techniques
- Supporting clinical trial manufacturing by conducting QC testing
- Leading the transfer of methods from Process Development to Quality Control.
- Leading qualification and validation activities
- Designing and executing stability programmes
- Leading investigations for OOS / QERs / Change Controls
- Managing GMP and SOP compliance
- Contributing to the development of the team, through line management and training of junior staff
Desired Skills and Experience
- Proven experience within Biotech / Biopharmaceutical / Biologics or related Industry experience
- GMP QC Experience
- Degree or higher degree in relevant life science
- Experience of biopharmaceutical and cell based techniques e.g. flow cytometry, mammalian cell culture, potency testing, aseptic techniques, qPCR
- Understanding of Cell Biology and Immunology
Full details will be provided on application. This is a permanent role, working 9am to 5pm, Monday to Friday.