Associate Research Scientist

Research Scientist

This Research Scientist performs studies supporting chemical characterization of materials to ensure safety and biocompatibility of materials for medical devices. Includes identification and quantitation of chemical compounds using advanced chemical instrumentation. Analytical method development and validation to support materials characterization of medical device components and solutions.

Responsibilities include:

• Conduct drug container and medical device material evaluations studying the extractable/leachable compounds that can partition from device materials into fluids that are infused/transfused.
• Conduct analysis of trace organic compounds for medical device materials using chromatography/mass spectrometry.
• Conduct elemental analysis for medical device materials using ICP/MS.
• Independently generate study designs/protocols, write and distribute final reports.
• Occasionally may work with samples that include human blood and blood components using procedural controls and personal protective equipment.
• Assist the lab team in managing a laboratory testing capability that provides comprehensive chemical evaluation of materials for use in medical devices.
• Assist the lab team supporting laboratory daily operations, calibrations and supplies.
• Provide technical input/content for analytical method development and review.
• Technical expert in the use and operation of ICP/MS and chromatography instrumentation with mass spectrometry detection.
• Review laboratory documentation and results produced by colleagues.
• Provide collegial support to fellow scientists.

This job position within the Business Unit – Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

Requirements include:

• Working knowledge of laboratory analytical chemistry including classical techniques and advanced instrument systems.
• Significant experience (5+ years) with the modern analytical tools and techniques of medical device and pharmaceutical product development. Must be experienced with with elemental analysis instrumentation including ICP/MS as well as gas chromatography (GC) and liquid chromatography (LC) equipped with mass spectrometry detectors.
• Significant experience with (5+ years) laboratory instrumental techniques, method development, method validation. Experience with and instrument system validation desirable.
• Solid experience with analytical mass spectrometry including use of advanced data processing systems.
• A solid study director with total accountability for scientific study design, study execution, issue resolution and completion through audit.
• Strong written and verbal communication skills in prior roles.
• Experience with FDA regulated laboratory environment of drug and medical device industries including GMP/GLP/GDP operations.
• Must be able to routinely perform analytical laboratory testing while also demonstrating critical thinking including study design, interpretation of complex data sets, propose next steps for investigations based on newly acquired data. Must have adequate structural chemistry knowledge to facilitate interpretation of mass spectral data.
• Bachelor's degree in chemistry is required. Advanced degree preferred. PhD in chemistry or a related discipline is preferred; alternatively, a Master's degree in Chemistry with specific and relevant experience in the areas defined under responsibilities and qualifications will be considered.

The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.