Associate Research Scientist (Medical Device)

Position is eligible to participate in a bonus plan with a target of 6% of the base salary. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

About the role

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.

The role is within the Business Unit – Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA, which is committed to protecting workers from health and safety hazards and the environment through an integrated management system certified to ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management Systems).

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 using ICP/MS.
• Independently generate study designs/protocols, write and distribute final reports.
• Occasionally 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.
• Support laboratory daily operations, calibrations, and supplies.
• Provide technical input/content for analytical method development and review.
• Serve as a 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.

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, including elemental analysis instrumentation (ICP/MS) and gas/liquid chromatography with mass spectrometry detectors.
• 5+ years of experience with laboratory instrumental techniques, method development, and method validation; instrument system validation experience desirable.
• Solid experience with analytical mass spectrometry, including advanced data processing systems.
• Proven ability as a study director with total accountability for scientific study design, execution, issue resolution, and completion through audit.
• Strong written and verbal communication skills.
• Experience with FDA-regulated laboratory environments in the drug and medical device industries, including GMP/GLP/GDP operations.
• Ability to perform analytical laboratory testing while demonstrating critical thinking, including study design, interpretation of complex data sets, and proposing next steps for investigations based on new data.
• Adequate structural chemistry knowledge to facilitate interpretation of mass spectral data.
• Bachelor’s degree in chemistry required; advanced degree preferred. PhD in chemistry or a related discipline is preferred, or a Master’s degree in Chemistry with relevant experience in the defined areas.
• Must be able to effectively speak, read, write, and understand English to perform essential functions, including independently understanding policies, procedures, and training materials in a heavily regulated work environment.
• Must be authorized to work for any employer in the United States; Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa.

Pay

Salary range: $85,000 – $100,000.

Benefits

• 401(k) plan with company contributions.
• Paid vacation, holiday, and personal days.
• Employee assistance program.
• Comprehensive health benefits, including medical, prescription drug, dental, and vision coverage.
• Life insurance and disability coverage.
• Wellness program.