Karen Rodriguez

Sr Associate II, Analytical Formulation Development at Rakuten Medical
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Contact Information
Location
San Diego County, California, United States, US
Languages
  • Spanish Native or bilingual proficiency
  • English Native or bilingual proficiency

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Pranjali Tambe

I have worked with Karen for over a year at Illumina and I can say that Karen is very detail oriented, motivated and proactive at her job. I had the pleasure to work with Karen on multiple sustaining projects as well as day to day manufacturing support activities and she has constantly demonstrated effective technical and engineering skills. Karen is able to effectively communicate her feedback as well as work with the team to explain and understand issues. Karen has always delivered results on time and ensures that work is being completed in timely and compliant way.

LinkedIn User

Karen is a highly capable engineer who picks up new manufacturing processes and technology quickly. Karen is customer focused and is a strong team player. She collaborates strongly across teams and delivers quality work.

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Experience

    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Sr Associate II, Analytical Formulation Development
      • Jan 2023 - Present

    • Sr Associate I, CMC Analytical Formulation Development
      • Jun 2021 - Jan 2023

    • Associate Researcher
      • Nov 2019 - Jun 2021

    • Italy
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Engineer 1 - Process Development
      • Jun 2017 - Oct 2019

      Led 8D investigation to isolate root cause of abnormal aHPLC results on Agilent 1290 Infinity II and 1100 Series systems, which impacted 33% of production builds including diagnostic product lines. +Collaborated closely with vendors and team of cross-functional experts to design strategic experiments. +Designed strategic experiments to isolate root cause, design solutions, and implemented permanent corrections into standard production process. Transfer new production processes into manufacturing from pilot phase. Identify key process deficiencies and led remediation project to optimize for future scalability. Sustain nucleotide manufacturing area to ensure product quality and continuity of production. Troubleshoot multivariate issues in a regulated environment and ensuring manufacturing needs are met. Investigate yield variance using statistical process controls, commonality analysis, and historical data reviews to drive process improvement projects. Trend common sustaining issues, present proposals to management based on technical recommendations, and drive projects to streamline workflows, reduce yield variance, and support cost savings initiatives. Own detailed quality management system evaluations per ISO 13485 standards to document technical assessment of potential risk to products, while adhering to global quality metrics and manufacturing shipment deadlines. Ensure maintenance of manufacturing area’s validated state, including designing of IQ/OQ/PQ validation requirements, test cases, and documentation. Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Research Associate
      • Jun 2015 - Jun 2017

      Maintained large inventory of patient-derived bronchial epithelial cell culture plates used to drive high throughput drug discovery assays.Characterized heterogeneous populations of human lung cancer stem cells using immunofluorescent staining and flow cytometry techniques.Optimized dosing protocols intended for use in high throughput screening assays, reducing operator contact time by 50% and reagents required by 30%.Researched and performed preliminary testing of new 3D cell culture mediums for high volume cell production.Developed automated liquid handling platform designed to maintain high volume of antibiotic-free human bronchial epithelial cell plate inventory.+Resulted in full automation of 80% of cell culture processes for an inventory of 900 plates, critically reducing operator contact time and improving assay robustness.+Collaborated with team of engineering and biology experts to design an integrated platform largely comprised from off-the-shelf automation components.+Authored detailed troubleshooting guides. Show less

    • Cell Core Intern
      • Jun 2014 - Jun 2015

    • Undergraduate Researcher
      • Apr 2012 - Jun 2014

      Study axon growth and gene expression patterns in differentiated stem cell transplants on mice in partnership with postdoctoral fellow Sandra Klein. +Maintained iPSC cultures and induced neural differentiation. +Processing of mouse brain tissue for cryoperservation + Immunofluorescent tissue staining Study axon growth and gene expression patterns in differentiated stem cell transplants on mice in partnership with postdoctoral fellow Sandra Klein. +Maintained iPSC cultures and induced neural differentiation. +Processing of mouse brain tissue for cryoperservation + Immunofluorescent tissue staining

    • Research Intern
      • Jun 2013 - Aug 2013

      Developed a virtual environment to support screening of a drug-like compound database using molecular docking simulation software DOCK. Developed a virtual environment to support screening of a drug-like compound database using molecular docking simulation software DOCK.

    • Office Assistant
      • Oct 2010 - Jun 2011

      Office and record-keeping, event coordination, planning, and setup. Played an active role in the organization of seminars, social events, and symposia. Office and record-keeping, event coordination, planning, and setup. Played an active role in the organization of seminars, social events, and symposia.

Education

  • University of California, San Diego
    Bachelor of Science (B.S.), Bioengineering and Biomedical Engineering
    2010 - 2015

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