Research Scientist

Conduct drug container and medical device material evaluations studying extractable/leachable compounds that can partition from device materials into infused or transfused fluids Analyze 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 and protocols, and write and distribute final reports Work occasionally with samples including human blood and blood components using procedural controls and personal protective equipment Assist the lab team in managing comprehensive chemical evaluation testing capabilities for medical device materials Support laboratory daily operations, calibrations, and supplies Provide technical input and content for analytical method development and review Operate ICP/MS and chromatography instrumentation with mass spectrometry detection as a technical expert Review laboratory documentation and results produced by colleagues Provide collegial support to fellow scientists Support occupational and environmental safety, compliance obligations, and continuous improvement of

ISO 14001

and ISO 45001 management systems Requirements Working knowledge of laboratory analytical chemistry, including classical techniques and advanced instrument systems 5+ years of experience with modern analytical tools and techniques in medical device and pharmaceutical product development Experience with elemental analysis instrumentation, including ICP/MS Experience with gas chromatography (GC) and liquid chromatography (LC) equipped with mass spectrometry detectors 5+ years of experience with laboratory instrumental techniques, method development, and method validation Experience with instrument system validation desirable Solid experience with analytical mass spectrometry and advanced data processing systems Experience as a study director with accountability for scientific study design, execution, issue resolution, and completion through audit Strong written and verbal communication skills Experience in an FDA-regulated laboratory environment in the drug and medical device industries, including GMP/GLP/GDP operations Ability to perform analytical laboratory testing and demonstrate critical thinking in study design, complex data interpretation, and investigation planning Adequate structural chemistry knowledge to interpret mass spectral data Bachelor’s degree in chemistry required Advanced degree preferred; PhD in chemistry or related discipline preferred Master’s degree in Chemistry with specific relevant experience may be considered Must be authorized to work for any employer in the United States; Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa Must effectively speak, read, write, and understand English Core Competencies Demonstrates expertise in analytical chemistry with a focus on drug container and medical device material evaluations, including proficiency in ICP/MS and chromatography techniques. Capable of independent study design, method development, and compliance with FDA regulations in a laboratory environment. Highest-signal resume keywords ICP/MS Expertise Chromatography Techniques Analytical Method Development FDA-Regulated Laboratory Experience Study Director Accountability ATS Optimization Keywords Hard Skills Analytical Chemistry Elemental Analysis Gas Chromatography Liquid Chromatography Mass Spectrometry Method Validation Data Processing Systems Study Design Complex Data Interpretation Structural Chemistry Knowledge Soft Skills Strong Communication Skills Critical Thinking Certifications & Qualifications Bachelor’s Degree in Chemistry PhD in Chemistry (Preferred) Master’s Degree in Chemistry (Considered) Industry Keywords Medical Device Development Pharmaceutical Product Development GMP Operations GLP Operations GDP Operations ISO 14001

ISO 45001

Occupational Safety Environmental Safety Tools & Technologies Chromatography Instrumentation Mass Spectrometry Detection Laboratory Instrumentation #J-18808-Ljbffr Jobtailor