Biotechnology & Life Sciences Consulting

Structure, progress, and efficiency for biotech product and process development.

Driving your vision through clear and structured goals that meet your deadlines and hit your targets.

Who I Work With

Built for teams launching or optimizing a product or process

Lurain BioConsulting provides consulting on operations and strategy, either as an advisor or through hands-on implementation, with engagements that are scoped to fit what you need.

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Research & Molecular Labs

Diagnostic and clinical labs performing assay or medical device development, NGS workflows, or needing technology transfer from R&D to Operations.

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CROs & Consulting Agencies

Partners who need an experienced hand embedded on a client program, or a specialist to fill a specific technical gap.

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Biotech & Pharma Operations

Operationally focused teams preparing for launch or scale-up, and needing quality systems and automation to get there.

What I Do

A partner for the full product lifecycle

Serving start-ups, CROs, and operationally focused companies, I bring structure and simplicity to complex, cross-disciplinary work across the full product lifecycle.

01

Product & Process Development

Structured, step-by-step plans that move products and processes from concept through development and toward approval, ready for the market.

02

Quality & Regulatory Pathways

Quality management systems and operational processes that meet your needs, in compliance with CAP/CLIA/FDA regulations or under Design Controls.

03

Automation & Digital Transformation

Leading the shift from manual, paper-heavy processes to efficient, digital, high-throughput laboratory systems.

Areas of Expertise

  • Research and Diagnostic Labs
  • Technology Transfer — Validations and Verifications
  • LIS/LIMS Development and Implementation
  • Process Scaleup and Increased Robustness
  • End-to-End Automation and Systems Integration
  • Molecular Biology Techniques
  • Next-Generation Sequencing (NGS)
  • Assay Development
  • CAP/CLIA/FDA Regulations
  • Design and Development under Design Controls
  • Technical Program/Project Director
  • Technical Writing
  • Project Management
Why Lurain BioConsulting

Operational readiness, built for deadlines

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Operational Readiness

Meets critical deadlines with structured, well-sequenced plans that keep programs on track.

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Automation-Driven Efficiency

Increases the efficiency of operations through targeted, end-to-end automation.

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Reduced Costs & Errors

Lowers operational costs and errors through robust, well-designed processes.

15+
Years in research, clinical, and industry labs
PhD
Chemistry, with chemical engineering & bioinformatics foundation
5
Organizations spanning academia, biotech, and start-ups
1
Individual — multidisciplinary background

"I don't just help out on projects — I drive structure, clarity, and progress."

Kaycee Lurain, PhD brings a multidisciplinary foundation in chemical engineering, biochemistry, and bioinformatics to every engagement — asking the smart, persistent questions that help teams refocus on what truly matters: needs vs. wants, and following through on what's been agreed to.

Learn more about Kaycee →

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