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. **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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 **Minimum Qualifications** + Bachelor’s, Master’s, or PhD degree in Chemistry, Biology, Material Science, or related technical discipline with 10 + years of industry experience + Minimum of 5 years of experience performing LC-MS analytical testing (prefer High resolutions MS) + Extensive knowledge and experience performing LC/MS separations and identification of unknowns and target compounds in the areas of extractables/leachable, materials, and polymer characterization **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 Chromeleon 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. + Experience and working understanding of cGMP, current ISO 10993 part 12, 18, FDA and ICH requirements + Experience managing direct reports (provide insights and advice for career advancement) + Ability to work and be effective with minimal supervision + Strong verbal and written communication skills Apply Now (https://www.jobs.abbott/us/en) * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com