about 1 year ago
We are seeking a fantastic opportunity for a Senior Scientist to work within a clinical staged cell therapy biotech who are the first company in the world to reduce a solid tumour by 50% in a certain type of cancer through the use of T-Cells.
*Be the SME for all technical operations in producing cell therapy products
*Oversee and maintain GMP manufacturing facility ensuring FDA, EU and MHRA guidelines are met.
*Demonstrate leadership skills to manage a team of scientists and manufacturing technologists working in a GMP facility.
*Be a troubleshooting expert for manufacturing process and systems.
*Provide a continuous improvement environment across manufacturing systems and the QMS
*Take suitable risk management practices in order to develop manufacturing process robustness
*Lead on manufacturing projects, tech transfer projects, and process development projects.
*Provide hands on training to the manufacturing group.
Qualifications and Experience:
*Ph. D in biomedical sciences/life sciences and strong understanding of T-Cell culture/immunotherapy with at least 4 years of experience within a ATMP or similar field in GMP production.
*Previous experience with leading a small team
*Working with MHRA and FDA regulations
*Experience working cross functionally with QC/QC