Industries & company size
One operating discipline. Any market, any size.
Nearly 20 years in FDA-regulated manufacturing, where quality, traceability and qualified suppliers decide whether you ship, built habits that work in any operation. Claraxis brings them to founder-led companies, growing manufacturers and large enterprises, as a fractional, interim or project-based operations leader.
01 What transfers
Six capabilities that work in any high-stakes plant.
Scale-up
From pilot batch to steady production.
Ran a global technology center’s pilot plant, moving products from the bench toward commercial manufacturing, and supported 350+ scientists.
Supplier qualification
Qualified, dual-sourced, relocated.
Led the relocation of a critical packaging supplier from Canada to the United States with supplier qualification and process validation, and no interruption to manufacturing.
Quality systems & audits
Inspection-ready, every day.
Planned and led FDA, GMP and ISO 9001 audits with zero major findings; fluent in validation lifecycles and ISO 13485.
Critical utilities & facilities
Systems that cannot go down.
Modernized a USP purified water system and ran utilities, facilities and $25M+ in annual operating and capital budgets.
Systems, data & AI
Decisions on live data.
SAP S/4HANA, warehouse management systems and AI-enabled operational dashboards, including 24/7 visibility into a GMP utility.
Cross-functional launch
Nine functions, one plan.
Designed the commercialization model behind 3× faster speed to market across a $6B portfolio.
02 Every stage
From a single plant to a global portfolio.
- Founder-led & small manufacturersA senior operator part-time: steadier plant, qualified suppliers, launch discipline and inspection readiness, without a full-time executive hire.Fractional
- Mid-sized & investor-backed companiesInterim plant or operations leadership, scale-up and integration of acquired brands into one operating model.Fractional or interim
- Large enterprisesA proven operator for a defined program: commercialization across a $6B portfolio, a critical utility modernization, a supplier relocation, a pilot plant serving 350+ scientists.Defined project
03 Markets
Deep in one market. Useful in many.
Claraxis is clear about where the experience is deepest, and where it brings operating discipline to an industry that is new to it.
Deepest experience
Consumer products, OTC & personal care
FDA readiness, USP water, scale-up and launch for OTC drugs, cosmetics, personal care and household products.
Close neighbor
Medical devices & life sciences
Validation lifecycles, supplier controls, CAPA and audit readiness carry over directly, including ISO 13485 quality systems.
Operating discipline
Industrial, advanced & high-reliability manufacturing
Scale-up to steady production, supplier qualification, traceability, critical facilities and SAP-based operations for programs that can’t slip.
Supply chain
Packaging, warehousing & distribution
Procurement, dual-sourcing, WMS and SAP, inventory and day-to-day performance.
Cybersecurity
Companies facing security requirements
With advisor Joe Oforiatta: governance, risk and compliance, including NIST and CMMC readiness for the defense supply chain.
Every engagement
The same standards
An NDA before any data, your site’s security and confidentiality rules, a weekly written scorecard, and work built to hand over.
Fractional · interim · defined project
Need an operator inside your leadership team?
Part-time, interim or project-based operations leadership for plants, supply chains and programs, at any company size. Kobe replies personally within one business day.