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Lead Research Scientist

2 months ago

San Diego, California, United States ACON Laboratories Full time

At ACON Laboratories, we are dedicated to advancing healthcare through innovative medical devices designed for the diagnosis of various health conditions. Our mission is to enhance efficiency and reduce costs for both healthcare providers and patients. We invite you to be part of our commitment to developing cutting-edge technologies that improve human health.

We are currently seeking a Lead Research Scientist to contribute to the design and development of in vitro diagnostic medical devices. This role requires the application of scientific methodologies and techniques acquired through education and relevant experience, adhering to standard operating procedures (SOPs). A solid understanding of experimental theory is essential for identifying and addressing challenges that may arise during the development process.

Key Responsibilities:

  • Engage in the design and development of Point of Care (POC) testing solutions, including lateral flow immunoassays and instrument-based immunoassays;
  • Conduct experiments aimed at enhancing and optimizing existing products to fulfill requirements related to sensitivity, accuracy, and shelf life;
  • Develop and execute validation and verification (V&V) study protocols for newly developed products;
  • Prepare documentation for the transfer of new products to manufacturing;
  • Conduct literature reviews and market research to understand the general applications of Point of Care clinical diagnostics;
  • Provide comprehensive feasibility analysis reports on potential new technologies;
  • Work autonomously or under the guidance of senior scientists or team leaders;
  • Participate in the development of assays for Point of Care tests;
  • Contribute to the optimization of existing assay systems to meet performance criteria;
  • Assist in the transition of newly developed products to manufacturing;
  • Design and develop innovative methods and technologies for new projects, analyze data, and generate detailed study reports;
  • This position requires on-site work.

Qualifications:

  • A Bachelor's degree in life sciences is required; a PhD is preferred, along with one year of postdoctoral research experience in biology or a related medical field (e.g., molecular biology, immunology);
  • A minimum of three years of experience as a scientist in the medical device or in vitro diagnostic industry;
  • Proven experience in the development of lateral flow tests for infectious disease diagnostics, fertility tests, and other lateral flow applications;
  • Experience in immunoassay development with instrument readouts;
  • Familiarity with HbA1C assay development;
  • Experience in preparing technical documentation to support regulatory submissions (e.g., 510K).

Essential Skills and Competencies:

  • Strong knowledge in molecular biology, immunology, and medical sciences;
  • Excellent analytical and problem-solving abilities;
  • Strong written and verbal communication skills;
  • Demonstrated patience, determination, and follow-through;
  • Project management experience and training;
  • Proficiency in statistical data analysis.

As a member of ACON Laboratories, you will benefit from competitive compensation and a supportive work environment. We encourage qualified candidates to consider a career with us.