Job Summary
This Research Scientist performs identification and quantitation of compounds. Perform studies supporting chemical characterization of materials to ensure safety and biocompatibility of materials for medical devices. Analytical method development and validation to support materials characterization of medical device components and solutions.
Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
Responsibilities
• Conduct drug container and medical device material evaluations studying the extractable/leachable compounds that can partition from the device material into fluids that are infused/transfused.
• 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
• Review laboratory documentation and results produced by colleagues.
• Provide collegial support to fellow scientists.
Requirements
• Requires working knowledge of laboratory analytical chemistry including classical techniques and advanced instrument systems.
• Requires significant experience (5-10 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 (5-10 years) laboratory instrumental techniques, method development, method validation. Experience with and 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.
• Advanced degree in chemistry is required. 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.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
