The company are now establishing their phase I and II manufacturing operations for their proprietary T Cell based therapies for cancer. The Lead Scientist will be responsible for managing operations on a day-to-day basis with the responsibility for building and leading a team. A core part of this opportunity is the chance to use your science and knowledge of T cell manufacture. Plus contributing to the strategic direction of the Manufacturing Group and company.
- Lead and manage a team of scientists in compliance to GMP with the responsibility for their day-to-day supervision, development, and motivation.
- Contribute to the design of manufacturing programmes with the Manufacturing Manager.
- Operate as an SME within the group for equipment, processes, operations, and troubleshooting.
- Lead tech transfer activities into and out of the facility
- Develop, review, prepare and submit GMP documentation e.g. BMR, SOPR’s change controls etc.
- Ensure compliance to GMP regulations and manage QMS activities.
- Identify the need for new operational systems or equipment when required to ensure operations continue to be effective and harness the latest technology.
- PhD in a relevant biological field or equivalent commercial expertise in GMP manufacture
- Experience of line management in a manufacturing environment
- Expertise of manufacturing T – Cells, CAR – T, Gene Therapies, Viral Vectors, or similar products.
- A good understanding of T Cells or Immunology
- Experience of working in a GMP compliant environment.
- Experience of Tech transfer, QMS management, and Aseptic processes.