They are currently manufacturing therapies for use in Phase I and II clinical trials with these progressing to their respective latter stages imminently. Their timelines for these to be manufactured on a commercial scale is compressed thus the increased importance of the MSAT Team in their GMP operations to achieve this and continue to evolve.
Please Note: You do not need direct ATMP manufacture experience for this role, although this is a definite advantage. However, you must have experience within a biologics / biopharmaceutical environment.
This is an excellent opportunity because you be joining a newly created MSAT team due to the changing needs of the business as they develop to be able to meet increased manufacturing volumes. You will be a Process Expert with the responsibility for providing front line process specific support related to production to ensure that all processes are delivered on time. To include the continuous improvement within their GMP operations to improve the quality and productivity of their group in line with GMP.
- Operate as an SME in manufacturing processes. Focusing on the manufacture of batches on time, in line with SOP’s and GMP.
- With the ability to use your expertise effectively in an influential position.
- Lead the troubleshooting of manufacturing processes
- Lead complex deviation investigations and then implement CAPA’s
- Monitor processes to ensure they are being followed during the manufacturing processes and in alignment with critical parameters
- Work with Tech Transfer experts to ensure processes are transitioned into the facility in compliance with GMP and performs to its intended purpose.
- Undertake process improvements
Desired Skills and Experience:
- Proven experience within Biotech / Biopharmaceutical / Biologics or related Industry experience
- GMP Expertise
- Experience in an MSAT or Process Expert or Similar position previously
- Experience of Clean room or Aseptic Techniques
- Experience of technical transfer
- ATMP manufacturing experience is advantageous but not 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.