Nuria De
About Nuria De
Nuria De is the Associate Director of Biologics Manufacturing Sciences and Technology at Bristol-Myers Squibb in New Jersey, with extensive expertise in drug substance manufacturing processes.
Current Position at Bristol-Myers Squibb
Nuria De currently serves as the Associate Director of Biologics Manufacturing Sciences and Technology at Bristol-Myers Squibb in New Jersey, United States. In this role, she oversees the development and commercial support of drug substance manufacturing processes specifically aimed at biologics and active pharmaceutical ingredients (API). Her responsibilities include leading a team of laboratory scientists and engineers who specialize in purification processes.
Previous Roles in Biologics Manufacturing
Before her current role, Nuria De served as the Associate Director of Biologics Manufacturing Sciences. During this time, she gained extensive experience in a variety of manufacturing processes, such as primary recovery, purification, and cryogenics. Her work has also involved the application of methodologies like Quality by Design and Design of Experiments to optimize manufacturing processes.
Educational Background in Chemical Engineering
Nuria De holds a comprehensive educational background in Chemical Engineering. She completed her Bachelor of Science in Chemical Engineering at the Universitat Autònoma De Barcelona, followed by another Bachelor of Science in Chemical Engineering from the University of California, Berkeley. She went on to earn a Master of Science from the Massachusetts Institute of Technology (MIT), and subsequently, a Doctor of Philosophy in Chemical Engineering, also from MIT.
Specialized Expertise in Biologics and APIs
Nuria De has specialized expertise in drug substance manufacturing processes for biologics and active pharmaceutical ingredients (API). She focuses on various areas, including Process Development, Process Characterization, Process Validation, and Manufacturing Support. Her experience also includes regulatory activities such as CMC authoring for IND and BLA submissions and participation in Regulatory Inspections and Pre-Approval Inspections (PAI).
Scientific and Regulatory Contributions
Nuria De contributes significantly to scientific and regulatory domains within biologics manufacturing. Apart from her hands-on scientific expertise, she is involved in authoring CMC sections for regulatory submissions such as Investigational New Drug (IND) applications and Biologics License Applications (BLA). She is also actively involved in Regulatory Inspections and Pre-Approval Inspections (PAI), ensuring compliance and quality in manufacturing processes.