Product and Process Scientist

Product and Process Scientist

The Product and Process Scientist is responsible for developing, optimizing, and supporting manufacturing processes and diagnostic products for PTS Diagnostics. This position works closely with Manufacturing, Quality Assurance/Control, Regulatory Affairs, and Engineering to ensure products meet performance, quality, and regulatory requirements throughout development and commercialization.

• Conducts special studies initiated from product failure, troubleshooting efforts, Regulatory requests, etc. Responsible for planning and executing experiments, characterization studies, etc.
• Coordinates monitor characterization for A1C product release. Conducts testing, analyzes data, and troubleshoots monitor lots.
• Responsible for membrane qualifications for Chemical Production.
• Conducts experiments to test system performance which may include chemistry, architecture, and/or analyzer aspects relating to sustaining and development activities.
• Serves 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.
• Supports Chemical Production during peak production times.
• Collects and analyzes data for process improvement of PTS diagnostic assays.
• Performs testing using a wide variety of scientific instrumentation such as reference analyzers, POC instrumentation, electrophoresis system, 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.
• Supports validation activities by writing and executing validation documentation and other related documentation as required by FDA regulations.
• Other duties and responsibilities as assigned.

• General knowledge of strip manufacturing, software, chemical production and developmental products.
• Able to work independently and collaboratively within a scientific team.
• 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.
• Detail oriented, analytical, problem solver.
• Ability to manage multiple projects simultaneously.
• Knowledge of Good Laboratory Practice in a regulated industry is preferred.

• 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.

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a "quality in everything we do" approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

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 midrange vision in connection with performing essential functions. Ability to work inside a laboratory.

PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

This Job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.