American Preclinical Services is hiring for an Analytical Chemist specializing in extractables and leachables. There are multiple job levels available for this role. 

This role performs data analysis and unknown identification using mass spectrometry, and operates chromatographic systems such as HPLC/MS/MS, ICPMS and GCMS to identify and quantify chemical components in extracts to determine degradation products, impurities, and unknown extractables and leachables. Adheres to regulatory guidelines and ensures that study timelines are met.

Responsibilities:

• Performs extraction on samples, and analysis and characterization of extractables and leachables from study-related materials.
• Operates a variety of chromatographic and spectroscopic systems to analyze biological and chemical elements as directed by assays or study protocols.
• Gathers and records data according to SOP and protocol guidelines.
• Performs technical evaluation of data to analyze, interpret and provide written reports on results.
• Works with other team members to interpret results from different instrument platforms, and work to identify any unknown compounds (structure elucidation).

Qualifications:

• Bachelor’s or Master’s degree in chemistry or related field.
• Three years’ experience using mass spectrometer (MS) in industry or advanced degree-related research required.
• Working knowledge of analytical instrumentation such as ICPMS, GCMS, or LCMS.
• Working knowledge of Good Laboratory Practices (GLP) and applicable ISO 10993 standards is preferred.
• Familiarity with E&L (extractables and leachables), and ISO 10993-18 knowledge preferred.
• Excellent oral and written communication skills.
• Working knowledge of word processing, spreadsheet, and analytical data analysis software.