Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. In 2017, Singulex filed a 510(k) pre-market notification submission with the U.S. Food and Drug Administration. The Singulex Clarity system and Singulex Clarity assay have the CE mark and are commercially available in Europe. Additional assays to detect and rule out infectious and inflammatory diseases are in development. Singulex is also developing a point-of-care platform and exploring applications beyond the clinical setting. For more information, please visit singulex.com, Opens a New Window. or singulexclarity.eu.
Singulex is seeking a Scientist to aid in the research and development of new and/or improved immunoasays on our Clarity™ in vitro diagnostic (IVD) platform. The Scientist in this position will help guide prototype immunoassays into new IVD products, working both independently and through others. Specifically, Singulex is seeking a scientist who has experience with the development of regulated diagnostic products.
- MS or PhD in Biological Sciences (including biology, biochemistry, bioengineering, biotechnology, biophysics, or similar) 2+(PhD) or 8+(MS) or 10+(BS) years of relevant experience in the assay development environment, preferably developing and supporting quantitative IVDs Strong knowledge of the design and development of immunoassays is desired Previous experience with bead-based assays is preferred Previous experience with assay development on clinical analyzer platforms is preferred Strong analytical skills in the areas of statistics, Design of Experimentation (DOE), non-linear fitting, and risk analysis (FMEA, Cause and Effect, Fishbone Diagram, etc.) is desired Familiarity with working in a Design Control environment is required Excellent written and verbal communication skills are essential Ability to effectively communicate and participate in solving technical problems across disciplines and departments including Assay Development, Engineering, Product Support, Software/Algorithm Development, and Quality Assurance is desired Familiarity with commonly used office productivity software (Microsoft Office Suite) as well as mathematical analysis/statistics tools Previous experience with biomarkers in infectious disease and/or cardiology is an advantage in this position
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· The Product Development Scientist will take ownership of certain sub-projects within the larger effort to develop new immunoassays on the Singulex Clarity™ platform, helping to guide these projects from Feasibility to Launch
· The person in this role will assist in the preparation of protocols and reports in accord with typical Design Control processes
· This Scientist may be asked to present data at interdepartmental meetings and small focus groups that may include representatives from outside parties.
· The Scientist may participate in the generation of peer-reviewed publications and/or the preparation and presentation of posters at scientific meetings or conferences
· The person in this role may directly supervise junior staff (research associates, technicians, or engineers) to accomplish the sub-projects within the larger development effort.
· This role will require the interaction with other line functions in the company such as Quality Assurance, Regulatory Affairs, Clinical Affairs, Operations, Product Support, Engineering, or Marketing.
Singulex provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Singulex complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leave of absence, compensation, and training. Singulex expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Singulex's employees to perform their job duties may result in discipline up to and including discharge.