Ph.D., Senior Validation Scientist, AMGEN
Dr. José I. López Pérez is a highly driven professional with over 4 years of experience in validation processes, including facilities, critical utilities, commissioning and qualification (C&Q) life-cycle, Quality and Compliance, analytical method performance, and project management in the pharmaceutical and biotechnology industry. He holds a bachelor degree in Physics (2010) and a Ph.D. in Chemical Physics (2014) from the University of Puerto Rico at Rio Piedras, United States.
In his professional career, Dr. López obtained valuable experience and extensive knowledge of FDA regulations, good manufacturing practices (GMPs), 21 CFR Part 11, computer systems validation (CSV), project life-cycle, cost and budget analysis, and business continuity.
As a project manager, he demonstrated success in achieving cost reductions and improving client satisfaction in customer-facing operations with the ability to analyze issues, devise continuous process improvements and incorporate business process initiatives to increase efficiency, streamline operations and decrease aggregate expenses with limited resources.
For the present, he is responsible for the execution and development of validation and quality assurance protocols, risk assessments, and critical utilities qualifications.
Dr. López consistently identifies and accelerates strategic measures to strengthen performance with sustained operational results, forging long-lasting client and business partner relationships to mutually benefit all stakeholders.