Associate Research Scientist

Fresenius Kabi • Lake Zurich, IL

7d • Onsite

About The Position

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.

Requirements

• Requires working knowledge of laboratory analytical chemistry including classical techniques and advanced instrument systems.
• Requires significant experience (5+ years) with the modern analytical tools and techniques of medical device and pharmaceutical product development.
• Must be experienced 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.
• Must have 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
• Must have 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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 for 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.

Benefits

• 401(k) plan with company contributions
• paid vacation, holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• life insurance
• disability
• wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level