PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success: People, Technology and Service.
This position will support the Global Product Development programs for PTS Diagnostics. The ideal candidate will have a proven in vitro diagnostic development track record including product development and sustainability. This position will deliver results in a fast paced setting, and be a contributor to product development, method validations and scientific strategies. This position will also work collaboratively with other scientists, but is able to function independently with minimal oversight.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Planning and executing individual experiments.
• Lead or be involved in cross-functional technology transfer teams across PTS sites in Indianapolis and California. These teams are responsible for the planning, coordination, execution, and communication of analytical process.
• Conducts experiments to test system performance which may include chemistry, architecture, and /or analyzer aspects relating to new product design and development activities.
• May serve as a resource for the department and project teams, proactively keeping colleagues aware of product knowledge and experience such as specifications, stability, reference materials, and any method development documentation.
• Prepares, formulates, and optimizes chemical reagents for analysis in support of product and development.
• Collects and analyzes data for development and improvement of PTS diagnostic assays.
• Performs testing using a wide variety of scientific instrumentation such as reference analyzers, POC instrumentation, electrophoresis systems, HPLC, microplate readers, etc.
• Interprets experimentation results to determine appropriate course of action. Acts as a sounding board for testing scientific hypotheses and as a stimulus for the attainment of the highest caliber of scientific thinking and experimentation.
• Prepare assay validation reports and other assay-related documentation as required by FDA regulations.
• Data entry and analysis:
o Enters data collected into Microsoft Excel files and other analyzers programs; analyzes and prepares formal reports.
o Ensures lab notebooks are up to date.
• Maintains and orders laboratory supplies.
• Able to work independently and collaboratively within a scientific team.
• Has displayed a proven scientific track record (e.g. instrumental in developing assays, solving problems, patent applications, etc.)
• Accurately record and interpret laboratory data. Be able to formulate conclusions and generate formal reports.
• Liaise with external organizations to advance product development.
• Ability to create and develop new ideas into actionable plans for new product prototypes. • Able to interpret and follow written and verbal instructions.
• Detail oriented, analytical, problem solver.
• Knowledge of Good Laboratory Practice in a regulated industry is preferred.
EDUCATION and/or EXPERIENCE
• Minimum of a Bachelor’s degree Microbiology, Biochemistry, Chemistry, Biology, or other related discipline and 5 plus years of relevant experience or Master's degree and 1 year of relevant experience in Medical device industry.
• Prior experience with diagnostics platforms is strongly preferred.
• Experience developing intellectual property and improving processes for medical diagnostics is a plus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to sit for prolonged periods of time, handling, typing, talking, listening, requiring clear near and mid-range vision in connection with performing essential functions. Ability to travel within the U.S. Ability to work inside a laboratory.
PTS, Inc. is an Equal Opportunity Employer.