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.comOpens a New Window. or singulexclarity.eu.
Singulex is establishing a diagnostic business for the Clarity System, system reagents, assay reagents and service (products) in the USA. The Sales Specialist, Dx is responsible for sales, revenue, product placement and customer relations in the defined territory. The position requires 50% travel or as needed.
Singulex is seeking a Senior / Principal Scientist to establish and lead a Process Optimization function within Product Development to support our Clarity™ IVD platform. This position will help to solve technical issues, implement scalable processes to aid in the standardization and uniformity of developed products, and continuously improve the Clarity™ platform. Specifically, Singulex is seeking a senior-level scientist who is well versed in best practices for IVD calibration / standardization, specification setting, and determination of proper release procedures for regulated in vitro diagnostics.
- MS or PhD in Biological Sciences (including biology, biochemistry, bioengineering, biotechnology, biophysics, or similar)
- 15+(MS) or 10+(PhD) years of relevant experience in the assay development environment, preferably developing and supporting quantitative IVDs
- Strong knowledge of immunoassays with extensive experience in troubleshooting problems that arise at the interface of assay processes and automated liquid handling.
- Previous experience with bead-based assays is preferred
- Previous experience with assay development on clinical analyzer platforms is preferred
- Experience in generating and/or revising product specifications based on empirical trending data is essential
- 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
- Familiarity with process control methods is desired
- Excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical scientific information to a wide range of audiences are essential
- Ability to effectively communicate and solve technical problems across disciplines and departments including Assay Development, Engineering, Product Support, Software/Algorithm Development, and Quality
- Familiarity with commonly used office productivity software (Microsoft Office Suite) as well as mathematical analysis/statistics tools
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead the technical efforts to optimize existing assays and processes, troubleshoot internal and/or customer issues, discover root causes, and implement fixes for specific issues relating to Singulex’s IVD platforms
- The person in this role will critically evaluate the technical processes utilized by Singulex in the development and production of various IVD assays toward continuous improvement (i.e. lot calibration, value assignment of controls/calibrators, reagent release, automated liquid handling integration, fluorescence reader integration, assay washing procedures)
- Allocate time between troubleshooting and optimization projects to ensure priorities are aligned with business needs
- Generate Technical Reports on the outcomes and/or resolutions of optimization activities and provide guidance to the organization on how to improve the system
- Revise product specifications based upon the results of investigations
- Solve potentially long-terms problems as an individual contributor or delegate tasks to direct reports or stakeholders from other departments
- Present data at interdepartmental meetings and small focus groups that may include representatives from outside parties. May represent the Company in external relationships including communications with customers, assay manufacturers, instrument manufacturers, or suppliers of critical components.
- May directly supervise junior staff (research associates, technicians, or engineers)
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.