Michael Boholst

About

Operations leader who joined Nucleus Biologics early and built the company’s pre-production and technical operations operating model end-to-end, including team buildout, KPI/dashboards, and regulatory readiness. Co-led ISO 13485 certification and managed capex and multi-year initiatives up to $10M. Notably mitigated a post-COVID supply chain crisis by designing an in-house manufacturing path for a critical sterile 2000L mixing bag/impeller (including CNC/prototyping and L&E considerations), eliminating vendor reliance and driving significant YoY savings.

Experience

Education

Key Strengths

• Built a pre-production and technical operations framework from scratch to enable predictable, compliant delivery
• Designed and implemented a unified operating model spanning PM, resource planning, validation, scheduling, and change control
• Hired and built cross-functional teams and established KPI-driven execution cadences
• Led ISO 13485 certification effort (co-led with Quality Director)
• Delivered predictable project execution with ~2-week margin and improved stakeholder visibility via dashboards/schedules
• Owned vendor coordination, capex planning, and multi-year initiatives up to $10M
• Solved critical supply chain constraint by bringing manufacturing in-house (sterile 2000L mixing bag/impeller), eliminating vendor dependency
• Created contingency plans and decision trees to secure executive/finance/quality buy-in for high-risk, high-cost initiatives
• Generated hundreds of thousands in YoY long-term savings through vertical manufacturing capability