CLARIFYSOP
v.2026.04 Portland, OR Available Q2 2026 Independent Consultancy

cGMP rigor, amplified by applied AI.

I help cell & gene therapy and biopharma teams ship safer products faster — by combining hands-on quality and manufacturing operations with practical, audit-ready AI tooling.

Two disciplines, one operating system.

01

cGMP & Quality Operations

Hands-on quality systems support for cell & gene therapy, viral vector, and biologics manufacturing — built for teams scaling from clinical to commercial.

  • Deviation, CAPA & change control authoring
  • Batch record review & disposition support
  • Audit & inspection readiness (FDA, EMA)
  • SOP architecture & tech transfer documentation
  • QMS gap assessments for clinical-stage biotechs
02

Applied AI for Regulated Industries

Practical, validation-aware AI implementations for life sciences teams — agentic workflows, retrieval systems, and decision-support tools that respect the rules.

  • AI-assisted document drafting & review
  • Custom GPT/Claude skills for QA workflows
  • RAG over SOPs, batch records & deviations
  • Workflow automation with human-in-the-loop gating
  • GxP-aware AI governance & risk frameworks

Five years, four labs, one throughline.

2024 — 2026
Vertex Pharmaceuticals
Quality Operations · Contract via Dexian
Cell Therapy
2022 — 2024
Vor Biopharma
Manufacturing & Quality · CAR-T Operations
CAR-T / Engineered Hematology
2021 — 2022
Bristol Myers Squibb
Cell Therapy Manufacturing
Commercial CAR-T
2020 — 2021
Thermo Fisher Scientific
Viral Vector Production
Gene Therapy Supply

Rigorous and warm. Precise and expansive.

I'm a biopharmaceutical quality and manufacturing professional with five-plus years inside cGMP environments — CAR-T, viral vectors, commercial cell therapy. I've authored deviations at 3am, sat through FDA inspections, and watched batch records become the nervous system of a clinical program.

I'm also a builder. I write Claude skills, ship side projects, and use AI tools daily — not as novelty, but as leverage. The interesting question for biotech right now isn't whether AI belongs in regulated environments. It's how we bring it in without breaking the trust that makes those environments work.

That intersection is where I want to spend my time. If you're a Portland-area biotech, a cell or gene therapy team, or a quality org wondering where AI fits — let's talk.

Let's build something.

[email protected]