Amy Gonzales, Cpim
About Amy Gonzales, Cpim
Amy Gonzales is a Senior Manager of Drug Supply at Aridis Pharmaceuticals, where she oversees IRT releases and manages packaging and labeling campaigns for clinical studies. With extensive experience in supply chain management across various pharmaceutical companies, she has played key roles in multiple clinical trials, including Phase 2 and Phase 3 studies.
Work at Aridis Pharmaceuticals
Amy Gonzales serves as the Senior Manager of Drug Supply at Aridis Pharmaceuticals, a position she has held since 2021. In this role, she is responsible for performing Interactive Response Technology (IRT) releases of approved materials for new releases and adding countries to previously approved materials. She also liaises with Qualified Person (QP) representatives for the QP release of products manufactured in the European Union. Her responsibilities include oversight of packaging and labeling campaigns to support various clinical protocols, including Phase 2 and Phase 3 studies.
Previous Experience in Clinical Supply Management
Prior to her current role, Amy Gonzales worked at OBI Pharma USA, Inc. as the Manager of Clinical Supplies from 2020 to 2021. She has also held positions at La Jolla Pharmaceutical Company as Supply Chain Manager in 2019 and at Accriva Diagnostics as Planner/Buyer in 2014. Additionally, she served as a Senior Strategic Planner at Receptos, a subsidiary of Celgene, from 2014 to 2018. Her extensive experience in clinical supply management spans various organizations and roles, contributing to her expertise in the field.
Education and Expertise
Amy Gonzales earned her Bachelor of Science (B.S.) degree in Biopsychology from the University of California, Santa Barbara, where she studied from 2000 to 2004. Her educational background provides a foundation for her work in drug supply management and clinical operations. She has developed complex forecasting models and tools to monitor supply and demand, enhancing her analytical capabilities in the pharmaceutical industry.
Career Development in Supply Chain Management
Amy Gonzales has a diverse career in supply chain management, beginning as a Production Associate at Invitrogen in 2005 and later working as a Manufacturing Scientist at Millipore. She progressed to roles with increasing responsibility, including Planner 2 at Illumina from 2006 to 2012. Her career trajectory reflects her growing expertise in supply chain processes and clinical supply management, culminating in her current senior management position.
Clinical Study Leadership
In her current role, Amy Gonzales is the program lead for a Phase 2 study and an upcoming Phase 3 study focused on Eosinophilic Esophagitis (EoE). She conducts supply and demand analyses to assess the impact of site inventory on patient visits, ensuring that clinical studies are adequately supported by the necessary supplies. Her leadership in clinical study management highlights her capability in overseeing critical phases of drug development.