• Requires working knowledge of laboratory analytical chemistry including classical techniques and advanced instrument systems.
• Requires significant experience (5+ 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+ years) laboratory instrumental techniques, method development, method validation. Experience with and instrument 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.
• Bachelor’s degree in chemistry is required. Advanced degree preferred. 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.
The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.