Job posting has expired

Senior Scientist

Equiliem
United States, Minnesota, St. Paul
Jan 23, 2025
Position Description-Senior Scientist Extractable and Leachable (contingent) The senior scientist will be responsible for performing liquid chromatography/mass spectrometry (LC/MS) and or gas chromatography mass spectrometry GC/MS, Extractable and Leachable (E&L) analysis and possibly method development support for the Science and Technology analytical chemistry lab located at Little Canada, Woodridge location. The position has responsibility for project-based MS data processing, accurate compound identification, quantification of unknowns and target compounds, sample preparation, and operation of MS instrumentation (LC and GC and ICP). The role functions as part of an analytical chemistry team following guidelines from ISO10993, GDP and GLP requirements in the medical device industry. Position Responsibilities Partner with biocompatibility customers to determine testing needs and suggest testing strategies Perform E&L method development and analysis (LCMS, GC/MS, ICP/MS) Perform sample preparation techniques (SPE, liquid extractions, concentration, etc) Conduct design of experiments 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 Basic Qualifications 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 extractables/leachable, materials, and polymer characterization Ability to collaborate and work as a team player Experience and understanding of cGMP, ISO 10993 part 18, FDA and ICH requirements Ability to work and be effective with minimal supervision Strong verbal and written communication skills Ability to prioritize and execute on daily project tasks Use of Microsoft Excel, Word and Power Point Desired/Preferred Qualifications Successful candidate will have experience with Triple Quad and Orbitrap LC/MS instrumentation, with extensive experience in small molecule LC/MS data analysis and unknown identification and quantification. In addition, this person should have a good understanding and experience in either GC/MS or ICP/MS analysis. The candidate will have experience partnering with clients, defining study plans, and leading problem solving initiatives. Additionally, candidates will have experience in a dynamic team environment, strong interpersonal skills, and a strong ability to understand MS concepts related to laboratory data interpretation. Knowledge of medical devices is preferred. The candidate will have excellent organizational and multi-tasking skills that are results oriented. The candidate will also have experience with documenting experiments in a highly regulated environment and knowledge of technical concepts and principals underlying Organic and Inorganic analytical chemistry techniques. Ideal candidate will be familiar with 1 or more Thermo Scientific software platforms such as Tracefinder, Excalibur and Compound Discoverer for LC/MS, Agilent Mass Hunter and Thermo's Chromeleon software for GC/MS and Thermo's Qtegra software for ICP/MS Familiarity with FTIR, Raman and SEM would be a plus.