Independent, senior-level ownership of the IT/OT workstream ... for biotechs, CDMOs, and pharma manufacturers running or building a GxP site, and for the EPCM and CQV firms delivering it for them. 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 pharma manufacturers hit the same wall: platforms multiplying, a new site on the horizon, auditors asking harder questions ... and no one owning the technology roadmap. EPCM and CQV firms running the build hit a version of the same wall: an IT/OT workstream that needs one accountable owner, not another vendor relationship. An independent consultant closes that gap: senior-level ownership, part-time or project-based commitment, no recruiting cycle.
Lab instruments, MES, historians, and cloud platforms operating in silos with no unified data or lifecycle governance.
A full-time senior technology hire runs $300k+ once you count salary, equity, and ramp time ... when your site only needs focused, hands-on direction 1–2 days a week.
Commissioning deadlines at risk due to uncoordinated IT/OT sequencing, cybersecurity blindspots, or non-compliant AI initiatives.
Ongoing, part-time ownership of 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 ... without the full-time headcount.
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. Whether you're the owner-operator or the EPCM/CQV firm running the build, 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. Senior-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.
Tell me where your site or roadmap is stuck. I'll tell you honestly whether an outside consultant is the right tool.