CDMO & contract manufacturer consulting
CDMOs scaling fast need quality and manufacturing infrastructure that keeps pace. I help build it without slowing you down.
The challenge
The CDMO sector is expanding aggressively - especially in cell and gene therapy. New manufacturing capacity means new quality systems, new supplier qualification programs, new tech transfer processes, and new regulatory filings. Most CDMOs are hiring as fast as they can, but specialized expertise in materials qualification, CMC documentation, and GMP readiness is hard to recruit for.
Why me
I've worked on both sides - as the person inside the company managing suppliers and writing CMC documentation, and as the person evaluating and qualifying contract manufacturers. I understand what CDMOs need to demonstrate to their clients and to regulators, and I can build the documentation that satisfies both.
How I help
Tech transfer support
Documentation packages for incoming tech transfers. Batch records, process parameters, validation protocols.
Manufacturing readiness
Gap assessments, equipment qualification support, process validation documentation.
Supplier qualification
Building or formalizing supplier programs for raw materials and components.
Quality system buildout
CAPA, change control, document control, deviation management - right-sized for your stage.
CMC documentation
Supporting your clients' regulatory filings with manufacturing-side CMC content.