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
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