Research Associate III

ABOUT SINGULEX: 

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. 

JOB DESCRIPTION:  

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.  

Qualifications:   

• BS or MS in Biological Sciences (e.g. biology, biotechnology, immunology, cell biology, biochemistry).  3-5 (MS), 5-8 (BS) years industry experience in a regulated environment (In-Vitro Diagnostic (IVD) and immunoassay development experience preferred).  Good understanding of immunoassay methods used for protein analysis (i.e. EIA, bead (e.g., Luminex platform), ECL, ELISA).  Must have strong written and verbal communication skills with a good level of computer literacy.  Experience with Excel, PowerPoint, and Word programs.  Clear understanding of the technology and components involved in the Singulex assays. 

Essential Duties and Responsibilities:    

· Demonstrates in-depth understanding and application of the technology encompassed in and practiced with the Singulex assays as well as basic immunoassay principles in planning, executing and evaluating experiments. Performs assays and data analysis with minimal supervision.   

· Operates lab instruments according to established procedures and prepares reagents as needed.  

· Analyzes human specimens (blood, serum and plasma) for specific analytes using Singulex or other immunoassays. 

· May be required to work non-standard hours; for example second shift, some weekends 

· With consultation may design and conduct product development experiments, assay optimization and scale-up tasks as part of a group effort coordinated by senior members of the team. May also, with consultation, be involved in planning, execution and documentation of experiments that support feasibility investigations for newly proposed projects. 

· Critically analyzes, summarizes and reports data generated from experiments, draws conclusions from experimental results and recommends and executes required follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision. Proposes new studies or investigations based on findings and efforts in relation to project needs. May work on independent projects. 

· Presents data at Team meetings or to small focus groups that may include representatives from other departments and/or outside parties, and participates in brainstorming and troubleshooting sessions within or between teams, offering and implementing solutions to problems. 

· Ensures compliance with and begins to implement the requirements of working in a regulated environment, assuring adherence to various requirements including Design Control, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Utilizes knowledge of basic scientific principles to assess experimental responsibilities and demonstrates a clear understanding of and applies the principles, requirements and practices of Product Development.  

· Performs and is involved in the planning and documentation of verification activities to ensure that newly developed products meet the pre-determined product specifications, and all applicable requirements of the Food and Drug Administration (FDA), Quality Systems Regulations (QSR), International Organization for Standardization (ISO), and CE mark.  

· May facilitate the transfer of Diagnostic Product Development processes to Manufacturing/Operations and is involved in completion and release of enabling documentation for newly developed products by ensuring all relevant technical information is incorporated into the appropriate documents. 

· Maintains familiarity with current technology related information and/or literature and conducts project related information searches and may be involved in extensive literature searches. 

· Trains others in laboratory procedures and processes, and in the design, execution and analysis of experiments. Provides feedback to Supervisor on training progress. 

· Performs and may oversee general laboratory tasks such as reagent preparation, inventory, laboratory clean up and organization of work.  

· Performs other duties and assumes additional departmental responsibilities as required. Performs other assignments and tasks as directed. 

· Demonstrates excellent written and verbal communication skills within and between departments. Maintains appropriate laboratory records, notebooks, and other formal company documentation, as required. 

· Works under minimal supervision, receiving no instructions on routine work, general instructions on new assignments, and detailed instructions or training on new applications or responsibilities 

· Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, and exercises judgment within broadly defined practices and policies to determine appropriate conclusion and follow up action.   

EQUAL OPPORTUNITY: 

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.