About the Company
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.
What will you do?
• Work closely with Process Development teams to assure process reliability and robustness in preparation for comparability and process validation.
• Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Work with vendors and suppliers to define requirements and understand functional specifications.
• Support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing.
• 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.
• Ensure successful manufacturing process comparability and process validation runs
• Participate in laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements.
• Bachelors Degree.
• Pharmaceutical Experience - 3+ years strongly preferred.
• CAPA / RCA experience.
• Experience working in Quality Systems.
• Technology transfer experience strongly preferred.
• Cell Therapy experience would be a plus.
If you think that you are suitable for this role then apply and you can get connected to me.