It is a biopharmaceutical company engaged in the development of innovative immunotherapies for cancer. The goal is to provide rapid, sustainable long-term response and remove the burden of chronic care. The company focuses on the cells of the immune system that detect disease and viruses (chimeric antigen receptor (TCR) and T cell receptor (TCR)). They seeks to recognize, kill and enhance these cells.
In Europe. They are recruiting talent to support the development of the European region. We are building a state-of-the-art factory in Hoofddorp for this purpose. Currently we are looking for motivated talent for different positions to support our innovative immunotherapy for cancer.
About the role
- You will work closely with Process Development teams to assure process reliability and robustness in preparation for comparability and process validation.
- You will participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
- You will participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
- You will work with vendors and suppliers to define requirements and understand functional specifications.
-You will support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing.
-You will write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, process and cell therapy manufacturing process validation testing).
-Participate and report to a cross-functional development team to advance production activities.
- Bachelors Degree
- Pharmaceutical Experience 3+ years strongly preferred
- Strong experience with CAPA/RCA
- Knowledge about Quality System
- Cell therapy experience is a plus