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

• 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

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.

• ICP/MS Expertise
• Chromatography Techniques
• Analytical Method Development
• FDA-Regulated Laboratory Experience
• Study Director Accountability

• Analytical Chemistry
• Elemental Analysis
• Gas Chromatography
• Liquid Chromatography
• Mass Spectrometry
• Method Validation
• Data Processing Systems
• Study Design
• Complex Data Interpretation
• Structural Chemistry Knowledge

• Strong Communication Skills
• Critical Thinking

• Bachelor’s Degree in Chemistry
• PhD in Chemistry (Preferred)
• Master’s Degree in Chemistry (Considered)

• Medical Device Development
• Pharmaceutical Product Development
• GMP Operations
• GLP Operations
• GDP Operations
• ISO 14001
• ISO 45001
• Occupational Safety
• Environmental Safety

• Chromatography Instrumentation
• Mass Spectrometry Detection
• Laboratory Instrumentation