Cristina Maldonado

Advancing OPEX in Life Sciences | Founder, Operational Excellence Network | MBA @ NC State |

Role
Senior Operational Excellence Specialist at KBI Biopharma
Location
Durham, NC, US
LinkedIn followers
500 followers

About Cristina Maldonado

Dynamic leader with expertise in biomanufacturing, Lean portfolio management, and process optimization. I design and implement scalable programs and systems that boost efficiency, promote continuous improvement, and align with strategic goals — all through cross-functional collaboration and data-driven decision-making.Strategic Thinker – I align operational initiatives and portfolios to drive organizational maturity and deliver measurable ROI.Collaborative Innovator – I lead high-impact, cross-functional teams and design tools and programs that simplify workflows and build a culture of excellence.Solution Architect – I turn complex challenges into clear, actionable solutions that lead to real-world results.I’m also the Founder of the Operations Excellence Network (OEN) — a growing community for Lean practitioners and professionals advancing operational excellence in the life sciences industry.Clifton Strengths: Achiever | Restorative | Ideation | Strategic | Responsibility

Experience

  1. Senior Operational Excellence Specialist

    KBI Biopharma

    Apr 2025 — Present

    Driving site-wide Operational Excellence initiatives to accelerate science and streamline biopharmaceutical manufacturing within the mammalian business unit. Partnering directly with senior leadership to deploy strategy, build governance systems, and embed Lean thinking across functions.Lead cross-functional continuous improvement projects that enhance efficiency, reduce waste, and strengthen process capability across departmentsFacilitate Hoshin Kanri strategy deployment, aligning site objectives with business growth goals through visual management and KPI cascades.Coach leaders and teams on Lean tools and problem-solving frameworks, cultivating a culture of accountability and continuous learning.Establish and manage the portfolio of OpEx initiatives, driving sustainable results through structured governance.Develop and streamline OpEx tools, tier boards, and reporting systems to enhance transparency and enable data-driven decision-making.

Education

  • NC State Poole College of Management

    Master of Business Administration - MBA

  • North Carolina State University

    Bachelor of Science - BS, Molecular, Cellular, and Developmental Biology

  • North Carolina State University

    Minor , Biotechnology

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Cristina Maldonado — Senior Operational Excellence Specialist at KBI Biopharma in Durham, NC, US | Unifers