Scientist I - CLIA

Biological Dynamics, Inc.
 San Diego, CA

Biological Dynamics, Inc. is a biotechnology company committed to improving global health outcomes by detecting disease in its earliest stages. Our proprietary Verita platform simplifies access to biomarkers, nanoparticles, and nucleic acids, enabling differentiated multiomics applications. We are applying our proprietary methods with machine learning to detect several diseases, including early-stage cancer, tuberculosis, and Alzheimers disease. For more information, please visit www.biologicaldynamics.com and follow us at @BiodynSD on Twitter.

Our talented staff thrives in an open working environment where curiosity, insights and vision are part of the equation. With an inclusive, family-friendly culture and comprehensive benefits package, we offer a terrific opportunity to discover, learn and grow. If you are ready to be inspired, challenged, and want to join a dynamic team where you can contribute to the next exciting breakthrough, we are the company for you.

Job Summary

The individual will provide technical and scientific support to CLIA Laboratory with designing and creating validation plans per CLSI guidelines and performing data analysis. The ideal candidate will have a strong background in clinical validations, reagent qualification, method development modification, parallel testing in a CAP/CLIA environment

Essential Job Duties

  • Lead planning, execution, and data analysis of analytical validations for protein assays laboratory developed tests.
  • Optimize laboratory processes transferred from R&D to the CAP/CLIA laboratory, ensuring full compliance with regulatory agencies.
  • Conduct analysis of performed studies and presents data to lab management and cross-functional teams.
  • Assist with troubleshooting, developing, executing, and optimizing protein-based assay.
  • Mentor and collaborate with other technicians in the department.
  • Provide clinical lab validation and support in pre-analytical, analytical, and pos-analytical processes.
  • Actively participates in assay optimization projects and provides technical expertise to improve lab automation platforms.
  • Develop sample QC assays to increase robustness of the assay to support clinical lab and meet CAP/CLIA requirements.
  • Provides technical and scientific support to the CLIA team.
  • In collaboration with R&D designs and executes experiments.
  • Aids with new assay development and validation.
  • Acts as liaison and technical expert between CLIA, R&D and other departments during new product and assay transfers.
  • Supports the submission of validation reports to CAP and NY State Dept of Health.
  • Ensures lab is in full compliance with regulatory agencies for newly developed assay. Lead planning, execution, and data analysis of analytical validations for protein assays laboratory developed tests.
  • Optimize laboratory processes transferred from R&D to the CAP/CLIA laboratory, ensuring full compliance with regulatory agencies.
  • Conduct analysis of performed studies and presents data to lab management and cross-functional teams.
  • Assist with troubleshooting, developing, executing, and optimizing protein-based assay.
  • Mentor and collaborate with other technicians in the department.
  • Provide clinical lab validation and support in pre-analytical, analytical, and pos-analytical processes.
  • Actively participates in assay optimization projects and provides technical expertise to improve lab automation platforms.
  • Develop sample QC assays to increase robustness of the assay to support clinical lab and meet CAP/CLIA requirements.
  • Provides technical and scientific support to the CLIA team.
  • In collaboration with R&D designs and executes experiments.
  • Aids with new assay development and validation.
  • Acts as liaison and technical expert between CLIA, R&D and other departments during new product and assay transfers.
  • Supports the submission of validation reports to CAP and NY State Dept of Health.
  • Ensures lab is in full compliance with regulatory agencies for newly developed assay.
  • Supports CLIA team with day-to-day troubleshooting of instruments and assay failures.
  • Recognizes technical issues impacting LDT performance and reporting of results and informs lab management and recommends effective solutions to the issues.
  • Supports lab management with preparations for regulatory agency inspections and ensures technical areas are inspection ready per accrediting agencies (CAP, NY, etc.).
  • Collaborate with R&D and other departments on instrument validation to ensure CLIA/CAP requirements are met.
  • Resolve discrepancies and deviations to expected processes and outcomes.
  • Collaborates with CLIA staff, R&D and Quality to initiate corrective actions, and proactively improves operational efficiencies.

Education/Experience/Skills

  • Typically requires a minimum of 6 years of related experience and a Bachelor's and/or a minimum of 4 years of related experience and a Master's degree in a scientific discipline; and/or a PhD in a related field; or equivalent combination of education and experience.
  • Clinical Laboratory License preferred. Minimum of 2-3 year of relevant experience (5 years highly desired) leading or actively participating in hands-on LDT analytical and clinical validations in Biotech or reference laboratory environment.
  • Extensive knowledge of common laboratory techniques, CLSI, CAP, and CLIA guidelines. Strong experience with statistical tools and analysis.
  • Previous experience in assay development/validation desired.
  • Experience setting-up and qualifying new laboratory equipment/analyzers.
  • Clinical Laboratory Scientist with CAP/CLIA experience OR equivalent education and CAP/CLIA experience.
  • Ability to support CLIA personnel with training on the new assay.
  • Experience developing and designing validation studies.
  • Knowledge of biology, genetics, and oncology and their application to molecular diagnostic testing. Self-starter. Ability to work independently and in a cross-functional team environment.
  • High level of organizational, attention to detail, and presentation skills.
  • Strong understanding of analytical techniques, data analysis, knowledge of liquid biopsy protein based LDT assays.
  • Experience in participating or leading assay development/validation of protein based clinical assays.
  • Strong drive to start and finish project timely with high degree of accuracy.
  • Ability to manage and lead cross functional projects in a highly collaborative and matrixed environment.
  • This position will require bench work.

The health and well-being of our employees is of utmost importance. As the COVID-19 cases persist, Biological Dynamics now requires proof of COVID vaccination for all employees (subject to limited exceptions) as a condition of employment beginning November 15, 2021.

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