Justyna Piasecka
About Justyna Piasecka
Justyna Piasecka is a Senior Process Engineer at Kite Pharma with extensive experience in biotechnology and regulatory compliance. She holds an MSc in Biotechnology from the University of Warsaw and a PhD in Molecular Biology from Maynooth University.
Current Role at Kite Pharma
Justyna Piasecka has been serving as a Senior Process Engineer at Kite Pharma since 2020. In this role, she is responsible for technology transfer and process validation within the commercial operations of cell therapy processes, specifically CAR-T, in the EU. Her work includes delivering data analysis, report writing, and presentations at stakeholder meetings, both internally and externally. She plays a crucial role in ensuring compliance with regulatory standards and optimizing processes for cell therapy.
Education and Expertise
Justyna Piasecka holds a Master of Science in Biotechnology from the University of Warsaw. Additionally, she earned a PhD in Molecular Biology from Maynooth University. Her educational background provides her with a strong foundation in the life sciences, which she applies in her professional roles. She possesses extensive knowledge of CMC development strategy, including process development and validation, and product characterization.
Professional Experience
Justyna Piasecka has a diverse professional background in academia and industry. She worked at Maynooth University in various capacities, including as a Demonstrator and Research Assistant, from 2007 to 2011. She also held positions as a Research Assistant at Swansea University from 2012 to 2018, contributing to the Institute of Life Science and College of Science. Prior to her current role, she worked as a Senior Scientist R&D at Lonza for eight months in 2018-2019.
Regulatory Knowledge and Compliance
Justyna Piasecka has a strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements from agencies such as the FDA, EMA, and ICH. She acts as a Subject Matter Expert for process and process-related regulatory filings, including material and equipment. Her expertise in regulatory compliance is essential for ensuring that processes meet industry standards.
Research Contributions
Throughout her career, Justyna Piasecka has contributed to various research projects, particularly in the field of life sciences. Her experience includes conducting root cause analysis and providing impact assessment reports for process deviations. She has also been involved in data analysis and report writing, which are critical for maintaining quality and compliance in research and development.