I've done the work I consult on. That's the difference.

My career started in the oil and gas industry as a chemistry tech, then moved into pharmaceutical development at DPT Laboratories, where I spent nearly five years taking drug products from formulation through FDA approval. I was the lead scientist on Ermeza (levothyroxine oral solution) - I designed the manufacturing process, ran validation campaigns, managed stability programs, and authored the CMC sections that supported a successful NDA. That experience taught me what it actually takes to get a product from bench to commercial manufacturing in a regulated environment.

From there I moved to Luminex Corporation (now DiaSorin), where I worked in ISO 13485 medical device manufacturing - managing design transfers, running CAPA investigations, driving process automation improvements, and bridging engineering and operations during new product introductions.

Then to Kite Pharma (a Gilead company), where I served as the global point of contact for single-use plastic materials across CAR-T manufacturing sites. I completed 50+ material impact assessments, led FMEA revisions, managed supplier change notifications, and drove an alternate supplier qualification program that reduced single-source risk on critical raw materials.

Most recently, I've led the end-to-end consumable qualification program for a commercial CAR-T therapy transitioning to automated manufacturing - covering 10+ ISO 13485 suppliers, custom connector development, and a 9-phase qualification framework that's the critical path for the regulatory filing.

I started Marshall GxP Consulting because the same gap keeps showing up: companies building world-class products but struggling with the materials, supplier, and manufacturing documentation that regulators actually want to see. That's where I work.