Kydah Dang

Senior Staff Engineer | 01/2022 - Present

Staff Engineer | 01/2018 - 12/2021

Process Development Engineer III | 01/2016 - 12/2017

Process Development Engineer II | 10/2012 - 12/2015

Lead team of engineers supporting early and late stage cell culture process development, with focus on cell line selection and cell banking, within Preclinical Manufacturing & Process Development (PMPD).

• Manage cross-department resources and logistics in collaboration with other sub-group leaders (e.g., daily operations, performance calibration)
• Partner with PMPD and Regeneron leadership to develop priorities and actions (e.g., revamp department career matrix, establish Lab Operations Group)
• Develop and transfer robust upstream processes to early clinical production (>20 successful processes to date)
• Guide and define success criteria for speed-to-clinic platform development
• CMC team representative for multiple programs, including Ebola, Zika, and COVID-19
• Contribute to authorship of IND, BLA, and other regulatory documentation
• Support department expansion across three new builds, including the Viral Production Core

Professional | 02/2010 - 09/2012

Associate Professional | 05/2007 - 02/2010

Lead member of the upstream process development group within Biologics Development Process Sciences to characterize and optimize microbial anaerobic (Clostridium botulinum) and aerobic (Escherichia coli) fermentation systems, subsequent scale-up, and technology transfer to GMP production.

• Scheduled and optimized resources and equipment utilization in the execution of fermentation and harvest processes at multiple scales
• Utilized QbD to plan and execute key experiments to completion and meet organizational milestones
• Successfully transferred process technology and knowledge to a multi-product GMP manufacturing site and provided technical support in the toxicology and clinical supply production
• Served as department safety representative, overseeing all aspects of departmental safety and adherence to the Federal Select Agent Program regulations
• Recipient of multiple Awards for Excellence in recognition of exemplary work at Allergan

Member of the process development team within Global Process Engineering for one of Amgen's blockbuster drugs, Neupogen®, whose goal was to comply with regulatory cGMP expectations by testing process robustness and accuracy of the operational ranges in Amgen's manufacturing procedures. This project had a challenging timeline and the full attention of Amgen's leadership.

Project Manager for an environmental consulting firm which delivered specialized environmental and safety performance solutions in the infrastructure, government, and property sectors.