Responsibilities:

• Perform E&L method development and analysis (LCMS, GC/MS, ICP/MS)
• Perform sample preparation techniques (SPE, liquid extractions, concentration, etc)
• Act as SME for external E&L studies to be a liaison to the CRO’s and biocompatibility team for study design
• Experience in statistical data analysis (Excel, Minitab, and JMP)
• Experience in protocol and report writing along with scientific data review
• SOP, Work Instruction and quality document writing
• Method Validation Guidelines SME, LCMS or GC/MS SME
• Perform pharmaceutical E&L study design, data collection and analysis (USP 1663 and 1664)
• Perform medical device E&L study design, data collection, material assessment and analysis (ISO10993)
• Operate and maintain triple quad LCMS and orbitrap LCMS systems
• Operate and maintain GC/MS and ICP/MS systems
• Analyze data with multiple software platforms, Ability to review, interpret and approve data
• Bachelor’s, Master’s, or PhD degree in Chemistry, Biology, Material Science, or related technical discipline
• Minimum of 5 years of experience performing LC/MS or GC/MS analytical testing (prefer High resolutions MS)
• Extensive knowledge and experience performing LC/MS or GC/MS separations and identification of unknowns and target compounds in the areas of extractable/leachable, materials, and polymer
• Experience and understanding of cGMP, ISO 10993 part 18, FDA and ICH requirements