Staff Toxicologist

Company: Abbott Laboratories
Location: Saint Paul
Posted on: March 18, 2023

Job Description:

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 115,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:We currently have an opportunity for a Staff Toxicologist. This onsite position may be based out of any one of the following business locations that the Global Toxicology Service organization supports:

• Plano TX
• St. Paul, MN
• Santa Clara, CA
• Sylmar/Los Angeles, CA
• Pleasanton, CA
• Temecula, CA
• Burlington, MASenior-level contributor responsible for serving as a lead SME in biocompatibility and focuses on the toxicological evaluation of products and technologies required for product approvals and patient safety of Abbott medical devices in accordance with applicable global regulatory guidelines.WHAT YOU'LL DO
  • Deliver toxicological risk assessments on medical device/component extractable and leachable studies.
  • Collaborate with analytical chemistry team in design of extractable and leachable tests (e.g., solvents, extraction conditions and duration, justification for single versus exhaustive extraction, etc.).
  • Calculate hypothetical worse case chemical exposure based on medical device composition (i.e., compositional profiling).
  • Review chemical characterization and biological evaluation plans and consult with biocompatibility scientists and engineers on the selection and design of bioassays.
  • Review evaluation reports and ensure compliance with applicable standards and FDA/ISO guidance documents within a risk-based framework; advise biocompatibility engineers and/or draft language on leveraging toxicological risk assessment to address applicable biological evaluation endpoints.
  • Collaborate with a cross-functional team to support multiple projects requiring toxicological risk assessment, ensuring timely completion of required tasks to meet project schedules.
  • Analyze chemical characterization test results to determine adequacy of data to meet requirements for systemic biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
  • Assist with regulatory submissions to global regulatory agencies to elaborate on the toxicology strategy and data in response to additional information requests and prepare technical summary documents.
  • Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of toxicological risk assessments and reports.
  • Maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
  • Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on Abbott medical devices and business.
  • Participate in development and implementation of overall toxicology strategies.
  • Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
  • Plans and organize project assignments of substantial variety and complexity.
  • Initiates or maintains schedule for projects and project milestones.EDUCATION AND EXPERIENCERequired
    • Bachelor's Degree in biology, biochemistry, toxicology, molecular cell biology, immunology or relevant engineering or scientific discipline
    • Minimum 9 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations that include toxicological risk assessment, with a focus in medical devices; professional experience in pharmaceutical toxicology and/or IND-enabling nonclinical safety will also be considered
    • Good understanding of and experience of applying the principles, theories, and concepts in biocompatibility per ISO 10993 and particularly parts -17 and -18
    • Extensive experience in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing
    • Experience working in Design Control environment
    • Demonstrated track record of innovative scientific accomplishments, approved patents and breakthrough technical contributions. Outstanding technical leadership skills
    • Ability to work in a highly matrixed and geographically diverse business environment
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
    • Ability to leverage and/or engage others to accomplish projects
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
    • Multitasks, prioritizes, and meets deadlines
    • Strong organizational and follow-up skills, as well as attention to detailPreferred
      • Master's Degree or PhD in relevant engineering or scientific discipline with a specialism relating to medical devices (advanced degree may substitute for portion of relevant work experience requirement).
      • Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment is a strong plus.
      • Experience working in a broader enterprise/cross-division business unit model.
      • Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
      • Experience working with internal and external scientific standard organization and influencing the development of and/or revisions to those standards.WHAT WE OFFERAt Abbott, you can have a good job that can grow into a great career. We offer:
        • A fast-paced work environment where your safety is our priority
        • Production areas that are clean, well-lit and temperature-controlled
        • Training and career development, with onboarding programs for new employees and tuition assistance
        • Financial security through competitive compensation, incentives and retirement plans
        • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
        • Paid time off
        • 401(k) retirement savings with a generous company match
        • The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: - Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The salary for this role is between:$90,700 - $181,300JOB FAMILY:Research and DiscoveryDIVISION:MD Medical DevicesLOCATION:United States > Minnesota> St. Paul > Woodridge : 177 East County Rd BADDITIONAL LOCATIONS:United States > Massachusetts > Burlington : 168 Middlesex Turnpike, United States > Pleasanton : 6035 Stoneridge Dr, United States > Santa Clara : 4551 Great America Parkway, United States > Sylmar : 15900 Valley View Court, United States > Temecula : Building E - TE, United States > Texas > Plano : 6600 Pinecrest, United States > Texas > Plano : 6901 Preston RoadWORK SHIFT:StandardTRAVEL:Yes, 10 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Abbott Laboratories, St. Paul , Staff Toxicologist, Other , Saint Paul, Minnesota