Research Scientist

RESEARCH SCIENTIST – R004770

 Summary

 Research Chemist performing identification and quantitation of compounds. Subject Matter Expert designing and performing 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 polymeric medical device components and related solutions.

Job Description

• Use modern chromatography/mass spectrometry techniques to conduct drug container material 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 current 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 well established procedural controls and personal protective equipment.
• Assist in managing a laboratory testing capability that provides comprehensive chemical evaluation of materials for use in medical devices and pharmaceutical containers. 
• Participate as lab team member providing a share of support for laboratory daily operations, calibrations and supplies.
• Provide expert technical input/content for analytical method development and review.
• Technical expert in the use and operation of instruments including HPLC, UPLC, GC and mass spectrometry.
• Expert knowledge in the application of mass spectrometry to chemical structure identifications of unknown compounds.
• Demonstrate excellent communication skills. Provide effective oversight and training support to team chemists.

Requirements

• Evidence of a distinguished career having depth of knowledge and experience in the subjects listed under “Principle Activities”.
• Experience in the practice and assessment of chemical characterization for medical device materials.
• 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 gas chromatography (GC) and liquid chromatography (LC) equipped with mass spectrometry detectors. Familiarity/expertise with elemental (atomic) spectroscopy (ICP or AA) is desirable.
• Significant experience with (5-10 years) laboratory instrumental techniques, method development, method validation and analytical instrument system validation.
• Must have solid experience with chromatography/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/TUV 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 of Science degree in Chemistry with specific and relevant experience in the areas defined under Principle Activities will be considered
• 8-10 years of relevant experience in the pharmaceutical and/or medical device industry with a compelling narrative of achievement in all areas of the essential duties.