Staff Scientist

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Woodbridge MN location in the in the Medical Devices Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Staff Scientist will be part of a technical team within the Global Biocompatibility Chemistry group to support Extractable & Leachable projects. This person will act a liaison to provide strategy and guidance to the project teams for internal and potentially external E&L studies. This person will partner with our internal biocompatibility group to ensure alignment with the internal and external requirements for E&L studies. A firm understanding of the current ISO 10993 parts 12 and 18 are required as well as current FDA methodology with regards to E&L. A subject matter expert in performing liquid chromatography/mass spectrometry (LC/MS) and or gas chromatography/mass spectrometry (GC/MS), E&L analysis with method development support for the Global Biocompatibility Chemistry lab located at Little Canada, Woodridge location. The position has the 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 ISO 10993, GDP and GLP requirements in the medical device industry

What You’ll Work On

• Execute E&L investigations and data analysis per current ISO10993-18 guidance along with meeting current FDA expectations
• Perform E&L method development, analysis and validation (LCMS, GC/MS, ICP/MS)
• Partner with biocompatibility and project team leaders to provide chemistry testing strategies
• Act as SME for external E&L studies to be a liaison to the CRO’s and biocompatibility team for study design
• Experience in protocol and report writing along with scientific data review
• Develop and perform sample preparation techniques (SPE, liquid extractions, etc)
• Conduct design of experiments
• Experience in statistical data analysis (Excel, Minitab, and JMP)
• SOP, Work Instruction and quality document writing
• Conduct laboratory analyst training and mentoring

• Method Validation Guidelines SME
• LCMS or GC/MS SME
  • Perform medical device E&L study design, data collection, solvent compatibility assessment and analysis (current ISO 10993)
  • Materials characterization as part of E&L utilizing multiple analytical techniques
  • Perform pharmaceutical E&L study design, data collection and analysis (USP 1663 and 1664)
  • 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
  • Experience to train and mentor analysts
  • Ability to review, interpret and approve data

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