Fractional CTO and advisory services for biotech and pharma manufacturers — without the full-time hire. Digital manufacturing and lab systems governance, plus greenfield site infrastructure oversight, built on 14+ years inside GxP operations at Moderna, Sanofi, and a commercial CDMO.
Commercial CDMO — Cell & Gene Therapy
Small and mid-size biotechs, CDMOs, and manufacturers hit the same wall: platforms multiplying, a new site on the horizon, auditors asking harder questions — and no one owning the technology roadmap. A fractional CTO closes that gap: executive-level ownership, part-time commitment, no recruiting cycle.
Lab instruments, MES, historians, and cloud platforms operating in silos with no unified data or lifecycle governance.
Full-time VP/CTO salaries reaching $300k–$500k+ when your site only requires focused, strategic direction 1–2 days a week.
Commissioning deadlines at risk due to uncoordinated IT/OT sequencing, cybersecurity blindspots, or non-compliant AI initiatives.
Ongoing fractional leadership over lab and manufacturing platforms — system lifecycle, data integration, instrument onboarding, vendor and budget ownership, and AI/agentic workflow evaluation inside GxP guardrails. The work of a Digital Lab Systems or Digital Manufacturing Director — at fractional commitment.
Strategic direction for IT/OT infrastructure on new-build GMP sites — sequencing systems against construction and commissioning, setting requirements, and reviewing the plan for GxP and cybersecurity readiness. Deep network and OT engineering is directed to trusted specialists; you get one accountable owner setting the standard, not a hiring project.
Reference architectures, prototypes, and operational platforms showcasing how I design compliant, high-leverage solutions for manufacturing sites. Click any walkthrough to see the system in action.
Directed design of a real-time SQDCI dashboard consolidating operations, quality, and exceptions into a single view for daily tier meetings — faster reaction, less downtime.
Governance-first AI assistant returning traceable, sourced answers from controlled SOP libraries — designed specifically for GMP environments and audit readiness.
Dual-role gated workflow that blocks go-live until both IT and science complete their checklists — eliminating stalled threads and missed cybersecurity reviews.
A live demonstration of how configuration traceability is brought into a GxP-compliant environment. Connecting systems, surfacing gaps, and keeping audit trails intact without the manual overhead.
Platform and system inventory, stakeholder interviews with engineering, QA, and IT, and a governance/lifecycle review against your GxP and commissioning timeline. Gap report you can act on with or without me. Deep network topology or OT segmentation design is coordinated with your (or a referred) network/security specialist — I direct that work, not perform it hands-on.
Roadmap, governance, vendors, team direction. Executive-level technology ownership on a part-time footprint.
On the ground through a build or go-live — sequencing infrastructure against construction, validation, and commissioning so go-live doesn't slip.
| Model | Annual Cost | Best For |
|---|---|---|
| Full-time CTO / Digital Director | $300k – $500k+ | Large sites with sustained, full-time technology headcount need |
| Interim (near full-time) leadership | $180k – $300k | Short-term leadership gaps, active search underway |
| Fractional CTO — regulated manufacturing Optimal ROI | $60k – $180k | Growing biotechs and CDMOs that need executive ownership without the full-time cost |
| Readiness Assessment (fixed scope) | Fixed fee | A single decision point — is your site infrastructure ready for what's coming |
General 2026 market ranges for regulated-industry technology leadership — not a quote. Your actual scope and pricing are set per engagement.
Tell me where your site or roadmap is stuck. I'll tell you honestly whether a fractional engagement is the right tool.