about 1 year ago
Looking for the next step up? Looking for a company who can provide an opportunity to play a part in shaping the growth in the Cell & Gene therapy market?
I am currently partnered with a global clinical staged biotechnology company who are committed to transforming the lives of patients with cancer. They have the hunger and drive to ensure they are developing the next generation of novel T cell therapies. My client take pride in working with the best-in-class technologies and nucleate top-tier laboratories from around the world.
You will be given the freedom to plan and execute a variety of QC assays (informational and release tests for manufactured products) such as flow cytometry, immunophenotyping, qPCR, sterility.
Ensuring GMP regulations are followed in conformance with FDA/MHRA. In addition, provide maintenance on equipment and assays relating to the manufacture of T-Cell based therapies.
Must be able to record information, interpret data and prepare technical reports relating to GMP work (BMRs, SOPs, deviations, Qualification reports) which will need to be presented in team meeting.
You will be asked to support change controls, quality deviations, out of specification results and quality/ business risks associated with area of responsibility are appropriately escalated.
Bachelor's degree in the biological sciences or related field.
Prior experience working with GMP regulations.
A minimum 2 years Quality control experience in a biotech, pharma or biologics operation.
Knowledge of Quality Management System elements and experience in maintaining and improving systems.
If you are looking to share an ambition of excellence and you are looking for a high paced work environment, this could be perfect fit for you.