Jim Axtelle

Jim Axtelle has over 20 years of experience in the medical device and pharmaceutical industry. Jim began their career at Abbott Laboratories, where they held various management positions, including Quality Control Manager and Compliance Manager. During their time there, they successfully managed the quality control group, oversaw the implementation of a new electronic corrective and preventive action program, and established compliant programs for the clinical chemistry design and development program.

Following their tenure at Abbott Laboratories, Jim joined Calando Pharmaceuticals as a Senior Project Manager and Quality Engineer. In this role, they managed the manufacturing campaign and quality assurance program for clinical trial materials. Jim also implemented document control and review programs and improved test methods, resulting in a significant reduction in method variability.

Currently, Jim serves as the Vice President of Operations at ChromoLogic LLC. Prior to this role, they were a Program Manager and Quality Assurance Director, responsible for the quality assurance program, regulatory strategy development, clinical trial monitoring, and program management for medical device development projects. Jim developed regulatory strategies, managed multiple device clinical trials, and ensured compliance with protocol and regulatory requirements.

Throughout their career, Jim has demonstrated strong leadership and expertise in quality control, compliance, and program management within the medical device and pharmaceutical industry.

Jim Axtelle attended UC Irvine from 1986 to 1988, where they obtained a Bachelor of Science degree in Biology.