A clinical stage T – Cell Therapy company who are pioneers in the sector with therapies advancing through clinical trials who have sites in the US as well as mainland Europe and advancing at a rapid rate are seeking a Director of Analytical Sciences.
The need for a specialist in this area is a reflection of the stage they are at where they continue to develop with therapies progressing through clinical trials and others crossing the translational gap. They are manufacturing therapies for use in Phase I and II clinical trials with these progressing to their respective latter stages this year. Thus, the need to recruit an experienced professional with an analytical sciences background to lead the strategy for their early and late stage clinical development programmes.
This is an influential position where you will have the opportunity to shape and direct the Analytical Development group who support the process development and the transition to GMP manufacture of their viral vectors and T – Cell Therapies.
The key responsibilities are:
- Lead T – Cell product and Viral vector – lentiviral and retroviral – characterisation, to take therapies and vecotrs from clinical development to registration
- Establish the Analytical Development and CMC Teams Develop strategies for both teams so they align, oversee the development of methods including FACS and flow cytometry
- Lead Product characterisation, CQA assessment, method development and optimisation, developing strategies for these areas
- Aim to have industry leading standards
- Author, review, and approve CMC documentation for regulatory submissions
- Work collaboratively with relevant departments such as R&D, Translational, Operational and Quality for example.
Desired Skills and Experience:
- You will need to have an MSc or PhD or relevant industry experience of Virology, or Molecular Biology or Cell Biology or other relevant area.
- Demonstrable experience of Analytical Development within the biopharmaceutical or preferably the ATMP / Cell Therapy sector.
- Expertise in late stage characterisation, risk assessment, method development, method optimisation, and validation.
- Experience of potency assays and / or cellular immunology is advantageous
- Knowledge of techniques such as mammalian cell culture, flow cytometry, FACS, ELISA and PCR for example
- Experience of leading teams is essential
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.