A clinical stage Biopharmaceutical company who are developing pioneering T Cell therapies for the treatment of cancer are seeking an experienced QC Team Leader with expertise in GMP to join their expanding manufacturing operations based in Stevenage. They are manufacturing therapies for use in Phase I and II clinical trials with these progressing to their respective latter stages soon. Thus, the need to recruit additional Team Leader to drive performance forward and expand the capabilities of the GMP Operations Group.
This is an excellent opportunity for a driven Team Leader to join a high performing group where you can make a difference. You will be managing a team of up to 4 scientists conducting quality control testing of T – Cell therapies for their release for use in clinical trials.
- Support the manufacture of life changing therapies by providing QC testing for in process, finished product and batch release testing,
- Manage the quality of the team’s work, compliance to SOP’s and GMP.
- Monitor and report on the performance of QC test methods using data trends
- Lead QER’s, Change Controls, CAPA’s etc.
- Lead Tech transfer of new methods into the QC Group.
- Ensure all test methods are correctly qualified / validated so that they are suitable for GMP manufacture
- Design and execute stability programmes.
- Contribute to the development of the strategy for the group and drive performance forwards.
Desired Skills and Experience:
- Proven experience within Biotech / Biopharmaceutical / Biologics or related Industry experience
- GMP QC Experience
- Supervision / Management with a GMP QC laboratory
- 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
The Company: The company are a pioneering and ambitious Biopharmaceutical company who have developed next-generation, programmed T-cell therapies to treat haematological cancers and solid tumours. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.