Greg Shoffner

Greg Shoffner has over 25 years of experience in various technical and leadership roles in the biopharmaceutical and manufacturing industries. Greg is currently serving as the Senior Director of Technical Operations at Dynavax Technologies, where they are responsible for developing and implementing technical operations strategies and overseeing manufacturing processes.

Prior to their current role, Greg worked as the Director of Quality Engineering at AveXis, Inc., where they built and managed a high-performing team that provided quality assurance support for a gene therapy manufacturing facility. Greg also developed and implemented startup strategies and change control programs.

Greg's experience also includes serving as the Director of Quality Engineering at AstraZeneca, where they built and led a quality engineering team for a new biologics manufacturing facility. Greg set quality strategies and supported deviation, change control, and procedure development and review. Greg also led the site validation team for manufacturing, facility, QC, and automation validation.

Before joining AstraZeneca, Greg worked as the Associate Director of Validation at KBI Biopharma, where they were responsible for the validation program, including cleaning, steaming, and laboratory system validation. Greg also led the cleaning validation planning and execution for a microbial molecule.

Greg has also held positions at Hospira, Amgen, Displaytech, Merix Corporation, and ENSR Consulting and Engineering. In these roles, they gained experience in validation engineering, process development, automation, and environmental consulting.

Throughout their career, Greg has demonstrated strong leadership skills and a track record of implementing process improvements and cost-saving initiatives. Greg has managed teams and successfully supported the startup of manufacturing facilities. Greg's expertise in technical operations and quality engineering make him a valuable asset to the organizations they have worked with.

Greg Shoffner completed their Bachelor of Science degree in Chemical Engineering from UC Santa Barbara from 1987 to 1991. Greg later pursued a Master's degree in Chemical Engineering from the University of Colorado Boulder from 1991 to 1994.