Sr. Scientist

1 month ago

San Diego, United States ACON Laboratories Full time

At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.


We are seeking a Sr. Scientist to join our team to participate in the development and design of medical devices for in vitro diagnostic applications. Work requires use of scientific methods, procedures, and techniques gained through training and/or previous experience in accordance with SOP standards. Uses understanding of theory behind experiments to identify and trouble-shoot situations needing special attention.


Some Essential Duties and Responsibilities:

  • Participate in the design and development of the test for Point of Care (POC) use including lateral flow immunoassay test and immunoassay with instrument read;
  • Participate in the experiments to improve and optimize the conditions of the existing product to meet the product requirement on sensitivity, accuracy and desired shelf life;
  • Development V&V study protocol and conduct V&V study on developed product;
  • Write the documentations for new product manufacturer transfer;
  • Understand the general application of Point of Care clinical diagnostic testing including doing literature review, patent search, existing products, search in the market;
  • Provide the study report on feasibility analysis of potential new technologies;
  • Work independently or under the supervision of the Senior scientist or team leader;
  • Participate in the assay development for point of care (POC) tests;
  • Participate in the experiments to improve and optimize the conditions of the existing assay system to meet the requirement of sensitivity, accuracy and the desired shelf of life;
  • Participate transferring the developed new product to manufacture production; and
  • Participate design, and develop new methods and technologies for new project, analyze data, and generate the study reports;
  • Require onsite work.

 

Education and /or Experience:

  • Bachelor’s degree in life science, PhD preferred with 1-year Postdoctoral research training in biology or related medical science, (molecular biology, immunology, etc.);
  •  3+ years’ experience as a Scientist in medical device or IVD industry;
  • Experience of Lateral flow test development for infectious diseases diagnosis, fertility test development and other LF tests development;
  • Experience of immunoassay development with instrument read;
  • Experience of HbA1C assay development;
  • Experience of technical file preparation to support regulatory 510K.


Required Knowledge, Skills and Abilities:

  • Knowledgeable in Molecular Biology, Immunology, Biology and Medicine;
  • Excellent problem solving and analytic skills;
  • Excellent communication skills both written and verbal;
  • Patience, determination and Follow-through;
  • Project management skills, knowledge and/or training; and
  • Skill in statistical data analysis.

 

As an ACON Labs team member, you’ll enjoy our competitive benefits and compensation packages as well as working in a supportive team environment. We invite qualified candidates to consider a career with us by submitting your resume.


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