• A key objective is to develop, test, characterize and support electrochemical ionophore based solid state sensors for measurement of electrolytes (such as Sodium, Potassium, Chloride & Ionized Calcium) in diluted serum, plasma and urine samples.
• Another objective of this position is to develop in vitro diagnostic assays and to transfer clinical chemistry assays to automated instrumentation.
• The candidate must have strong communication skills, the ability to work in cross-functional teams and to lead technical teams.
• The Senior Biochemist will report directly to the Senior Director of R&D and interface with Engineering R&D, Manufacturing, and Regulatory and Customer Support Organizations.
• Developing, testing and characterization of electrochemical ionophore based solid state sensors for measurement of electrolytes (such as Sodium, Potassium, Chloride & Ionized Calcium) in diluted serum, plasma and urine samples.
• Design and lead very research and investigations pertaining to the development of clinical chemistry and immunoassays.
• Assist in the transfer of designs into the overall product and manufacturing processes.
• Conduct design verification/validation studies according to quality procedures and prepare data summaries for regulatory submissions to the regulatory agencies.
• Will work as part of an interdisciplinary R&D Team in the development of novel sensor and membrane designs and to lead design improvement projects.
• Support troubleshooting efforts on commercial assays and sensors.
• Lead technical efforts in assay design and development.
Required Knowledge/Skills, Education, and Experience
• PhD or MS degree in Electrochemistry, Organic Chemistry, Biochemistry, Clinical Chemistry or related field.
• Minimum 5 years of relevant, combined experience with electrochemical potentiometric based sensors and/or in vitro diagnostics.
• Experience with membrane synthesis and characterization.
• Thorough understanding of organic and inorganic chemistry, molecular chemistry, and electrochemistry.
• Experience with polarographic and potentiometric analysis and other electrochemical techniques.
• Experience with immunoassays, enzyme reactions, ELISA and screening techniques.
• Expert analysis, testing and evaluation skills of sensor/system designs, sensor manufacturing processes and techniques.
• Expertise in accurate design of experiments, interpretation and presentation of experimental data and generation of clear and concise summary reports.
• Strong statistical skills and knowledge a must.
• Ability to establish manufacturable processes for developed products.
• Be able to provide expert consultation in a timely and efficient manner to resolve technical problems by identifying root cause and defining appropriate corrective actions.
• Experience with integrating designs into defined products along with expert assistance in integrating into manufacturing process for high volume production.
• Follow all relevant internal and external regulatory requirements.
• Candidate must have excellent verbal, written and listening skills and be able to present facts clearly and concisely to staff members at all levels.
• Candidate must have exceptional team skills and be able to work efficiently with associates at all levels of the organization.
Preferred Knowledge/Skills, Education, and Experience
• Experience in the development of in vitro diagnostic assays and sensors
• Experienced in working in an FDA regulated environment
• Familiarity of production/manufacturing processes
• Knowledge of design control