Title: Senior Research Scientist
Pay: $37.00 - $40.00/hour
Job Overview: Research Chemist performing 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.
· 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 other analytical and product testing for product support and for new product development.
· 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.
· Work in a laboratory testing capability that provides comprehensive chemical evaluation of materials for use in medical devices.
· Provide support for laboratory daily operations, calibrations and supplies.
· Provide technical input/content for analytical method development and review.
· Technical expert in the use and operation of HPLC, UPLC, GC chromatography techniques and instrumentation.
· Review laboratory documentation and results produced by colleagues.
- Requires working knowledge of laboratory analytical chemistry including classical techniques and advanced instrument systems.
- Requires significant experience (3-5 years) with the modern analytical tools and techniques of medical device and pharmaceutical product development. Must be experienced with gas chromatography (GC) and liquid chromatography (LC) equipped with mass spectrometry detectors.
- Knowledge of ICP/MS for elemental analysis of materials desired.
- Significant experience with (3-5 years) laboratory instrumental techniques, method development, method validation and system validation.
- Must have solid experience with chromatography/mass spectrometry including use of advanced data processing systems.
- Degree in chemistry is required. Advanced degree in chemistry or a related discipline is preferred; alternatively, a BS in Chemistry with specific and relevant experience in the areas defined under responsibilities and qualifications will be considered.
- 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, interpretation of complex data sets. Must have adequate structural chemistry knowledge to facilitate interpretation of mass spectral data.