About

Kyle Langham

Twenty years of data work inside regulated biopharma, at HGS, GSK and Novavax, across CMC, process development, analytical development, tech transfer, manufacturing, quality, supply chain and clinical. Now I build agentic AI systems on top of that experience, and the data foundations that make them possible.

HGSGSKNovavax Clinical → CMC → Supply chain
The twenty-year arc

Solving Data Problems

  • Human Genome Sciences
    Manufacturing

    Compliance and control MES data

  • GSK, Rockville
    Manufacturing

    SAP Data Migration

    Continued Process Verification

    eBR and Workplace Automation

    Business Intelligence

  • Novavax
    Development, Supply Chain, IT

    Process Data Management

    Tech Transfer Data Automation

    Business Intelligence

    Org-level Data Management and Engineering

  • Kyle Langham Consulting
    Now

    Now I build agentic AI systems that work across LIMS, MES, QMS and ERP inside GxP guardrails, plus the data foundation work that makes those systems possible. The AI is the return on fixing the data. It is not a substitute for fixing it, and I will tell you when the foundation is not ready.

Functional coverage

I have sat on most sides of the table.

You do not have to explain your workflow to me before the conversation gets useful.

CMC Process development Analytical development Tech transfer Manufacturing Quality assurance Quality control Supply chain Clinical IT PMO
21 CFR Part 11 ALCOA+ Continued Process Verification Validation support Master data management Data integration Business intelligence Enterprise migration
How I'm set up

One person, deliberately.

What you get. The person you meet is the person who does the work. There is no junior staffing model underneath me, no engagement where a partner sells it and an analyst delivers it, and no bench I need to keep busy, which means I have no structural reason to tell you a project is bigger than it is. When you send an email you reach me. For your IT and security group it also means there is no subcontractor or offshore team to vet, and nobody else who ever holds your credentials or your data.

What you don't get. I cannot put six people on something next month. There are engagements that genuinely need a firm, and if yours is one of them I would rather say so early than take it and staff it badly. I am also a single point of failure in a way a firm is not, which is a fair question to ask me about, and I will give you a straight answer about how a given engagement is structured to handle it.

Contact

Direct, always.

If you are here because someone referred me and you are checking whether I am real: the LinkedIn profile has the employment history and the working demos are posted there. If you would rather just ask me something, the email above reaches me directly.

Tell me what your team spends its week on.

Thirty minutes. I'll tell you whether an agent can run that workflow today, and what your data would have to look like first.

30 minutes on your workflow, no pitch