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Cristina Maldonado

OPERATIONAL EXCELLENCE LEADER | FOUNDER | mba CANDIDATE

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My Story | Accomplishments | Portfolio

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my story

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my impact

portfolio

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Experience & accomplishments

Business operations specialist-
operational excellence

Resilience- gene therapy

Founder/Chair

operational excellence network
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  • Leading the creation of a professional networking organization dedicated to advancing operational excellence in the life sciences industry.

  • Secured sponsorships and funding, established a board of directors, and assembled a leadership team to oversee strategic initiatives.

  • Developed the organization's mission, vision, and value proposition to serve as a forum for sharing innovative ideas, best practices, and thought leadership.

  • Preparing for an official launch, focusing on fostering community engagement, organizing networking events, and creating resources for lean practitioners and operational excellence professionals.

  • Optimized and governed the Lean Project Portfolio, advancing maturity from 3.1 to 4.5 in 15 months while delivering $1.8M in cost avoidance, saving 21,000 hours, and driving key site metrics (ATSQ, OTBR, RFT) and supported 47% deviation reduction

  • Designed and implemented an ROI tracking platform, developing the process to capture $3.5M in cost avoidance and save over 40,500 hours, supported by a custom-built dashboard to monitor and trend data.

  • Established a site-wide risk register in collaboration with senior leadership, overseeing risks and driving accountability through monthly reviews, ensuring timely closure and effective mitigation actions.

  • Designed the Lean Champion Program and Human Performance, leading a cross-functional team of people managers and senior site leaders,  achieving a program maturity increase from 0 to 3.0 in 7 months 

  • Facilitated Lean training for 200+ employees across multiple sites, including delivering presentations through a lunch-and-learn program, achieving 80% participation at RTP and advancing Lean adoption.

  • Supported multi-site deployment of the tier system, ensuring integration to maintain operational alignment.

  • Provided guidance, support, and training to the direct business operations team as a dotted-line leader, driving performance management by offering constructive feedback, setting clear expectations

co-lead- women in stem employee resource group

Resilience- gene therapy

laboratory manager, upstream

biomanufacturing training center, nc state university
  • Visionary for Employee Resource Group (ERG) focused on empowering women in STEM within the organization 

  • Established Mission Statement, Business Value Proposition, and Objectives, achieving a 60% site workforce engagement rate

  • Managed  budget and accounting operations, ensuring responsible allocation of resources

  • Organized and facilitated events, including lunch and learn educational sessions

  • Representative speaker for Town Halls, employee facing engagements, and conferences, advocating for gender equity in STEM fields

  • Led process optimization projects using 2L bioreactors, using an analytical approach to enhance the quality team’s technical knowledge and presenting results to the biomanufacturing department

  • Managed five laboratory spaces, implementing robust lab policies and enhancing standard operating procedures (SOPs). Applied 5S principles, achieving a 7.5% reduction in lab preparation time and boosting efficiency.

  • Mentored students and interns in upstream biomanufacturing and molecular biology, fostering the development of technical skills and advancing their proficiency in core concepts.

  • Co-chaired the outreach committee, leading strategy and relationship-building projects through cross-functional collaborations with biotechnology companies and educational institutions.

  • Developed a marketing communication plan to strengthen business relationships with alumni and enhance brand visibility.

biology laboratory technician

Corning life sciences

research technician

duke university
  • Collaborated cross-functionally with supply chain and manufacturing managers, utilizing theGemba Walk method to enhance efficiency in quality laboratory operations.

  • Revamped quality, scientific, and safety SOPs, surpassing Kaizen recommendations by400%, leading to improved accuracy, reduced errors, and increased productivity.

  • Optimized the product testing schedule and in-bound product processing, achieving a 72-hour reduction in lot release time for new and existing testing procedures, enabling faster turnaround times.

  • Forecasted and ensured availability of laboratory inventory for 30 microbial, environmental monitoring, and cell culture assays, mitigating disruptions during periods of supply chain ambiguity.

  • Trained incoming laboratory personnel during a 66% hiring increase, ensuring compliance with GLP, cGMP documentation, and ISO 5 cleanroom protocols and techniques.

  • Performed mammalian cell culture assays, microbial testing, sterility testing, environmental monitoring, and monitored testing excursions with consistent accuracy and precision.

  • Led the establishment of a new research laboratory focused on small cell prostate cancer, authoring 50 experimental protocols and creating comprehensive guidelines for molecular projects.

  • Implemented an inventory system to streamline lab operations and support research progress.

  • Mentored and supervised undergraduate interns, providing hands-on training in microbial and genetic engineering processes, demonstrating strong communication and leadership skills.

  • Demonstrated project management expertise by maintaining a well-organized schedule for DNA cloning projects, ensuring the timely completion of lab initiatives through effective coordination.

  • Successfully cloned 30 genes via transfection with 293T adherent mammalian cells, using techniques such as shake flask production, digestion, transformation, DNA extraction, gel electrophoresis, and lentivirus production.

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education & credentials

Masters of Business Administration ( MBA)

NC State University | 2025

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Bachelors in Molecular Biology

Minors in Biotechnology

NC State University | 2018

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Six Sigma Green Belt

The Council for Six Sigma Certification | 2023

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Kepner- Tregoe Foundations

Situational Appraisal | 2024

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awards

BTEC House Cup | BTEC

Recognizing Excellence | Corning Life Sciences

NASA Aerospace Scholar |NASA

Dean's List | NCSU

Provost Professional Experience Scholarship | NCSU

interests

Empowering women in STEM fields

Mindfulness meditation

Family BBQ's

Western classical music​

Connect | collaborate with me

Data Processing
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