01 Background
I've spent 15 years in FDA-regulated manufacturing.
I co-founded Earthsome Labs, an FDA-registered OTC drug and food facility in Texas, and built its quality system from scratch: 76 SOPs across six regulatory frameworks at once (21 CFR 211, 21 CFR 117, USDA Organic, Texas DSHS, TTB and the OTC monographs).
I'm not a molecular biologist. I'm the operator who gets biology through the audit, the batch record and the approval process.
02 Where I'm headed
Engineering biology to extend healthy human life. Genome writing is becoming affordable, aging is becoming measurable, and the FDA is starting to talk about both. The companies that turn that science into therapies will need fabs, quality systems and a clear path to approval. I intend to help build them.
03 Writing
Notes from the build: what it takes to get longevity and synthetic biology through manufacturing and approval.
First post coming soon.