Daniel Candelario

Daniel Candelario has extensive experience in the pharmaceutical industry, with a focus on quality systems and validation. Daniel began their career at Lederle Parenterals/Wyeth, where they worked as a Technical Services Scientist and Process Manager, providing technical support and troubleshooting in the penicillin lyophilization manufacturing plant. Daniel then moved on to Esi Lederle Inc as a Research Associate, where they were responsible for development, demonstration, and submission batches, as well as compiling documentation for regulatory submissions.

In 2003, Candelario joined Cardinal Health as a Validation Manager, overseeing the validation of various equipment and utilities supporting sterile manufacturing operations. Daniel also played a key role in the validation strategy for a monoclonal antibody for a leading human therapeutics company.

In 2006, Candelario joined Genentech as a Principal Technical Manager, taking on multiple roles including Quality Validation, CMO Ops Site Manager, and Quality Principal. Daniel provided direction and management for qualification and validation activities across the network, ensuring adherence to quality requirements and industry standards.

Most recently, Candelario has been working at Ultragenyx since 2016. Daniel has held several executive director roles, including Executive Director Quality Systems and Executive Director CMC QA. In these positions, they have focused on developing strategies for quality product delivery throughout the product life cycle and across technologies and modalities.

From 1989 to 1995, Daniel Candelario attended the University of Puerto Rico-Mayaguez, where they obtained a Bachelor of Science degree in Chemical Engineering.