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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 Title

Principal/Sr. Principal Toxicologist

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

The Principal/Sr. Principal Toxicologist works out of one of the following locations: St. Paul, MN (preferred), Plano, TX, Santa Clara, CA, Sylmar, CA, Pleasanton, CA, Temecula, CA or Burlington, MA and will serve the Global Biocompatibility Team, with responsibilities for medical device biological evaluation spanning:

• Cardiac Rhythm Management

• Electrophysiology

• Heart Failure

• Neuromodulation

• Structural Heart

• Vascular

Our Medical Device businesses have created a broad range of life-changing Cardiovascular and Neuromodulation devices. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. The extensive Vascular portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Abbott therapies for Heart Failure include Cardiac Resynchronization Therapy, Heart Pumps, and Pulmonary Artery Pressure Monitoring. Our comprehensive Structural Heart portfolio includes transcatheter and surgical valve solutions as well as structural interventions for congenital defects and stroke risk reduction. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Collectively, the Abbott Medical Device portfolio is designed to treat an expansive range of patients with a variety of acquired and congenital health conditions.

This is a senior-level technical contributor and supervisor responsible for serving as a lead SME in biocompatibility, focusing on the toxicological evaluation of products and technologies required for product approvals and ensuring patient safety in accordance with applicable global regulatory guidelines.

What You’ll Work On

• Collaborate with cross-functional teams from medical device business units and provide guidance and input to project teams

• Assess biological safety and toxicology on product across all developmental phases and through the full product life cycle to ensure that released designs continue to meet biological safety requirements

• Deliver toxicological risk assessments on extractables/leachables and device/materials constituents (compositional profiling) per ISO 10993-17 and ISO 10993-18 using sound scientific principles

• Support the biological safety of product following changes on released products (i.e., process improvement, optimization, etc.) to maintain ISO 10993 compliance

• Serve as primary interface and partner with internal analytical laboratories and external approved analytical laboratories on the chemical characterization

• Provide guidance in designing and conducting toxicity studies to meet biological safety requirements

• Review chemical characterization and biological evaluation plans and reports in compliance with applicable regulations, standards, laws, etc. regarding biological safety and toxicology endpoints

• Engage with regulatory bodies on the global biological safety regulatory submission strategy and author/review toxicology and biological safety sections

• Consult on the biological safety and toxicology impact of medical device field issues

• Perform and assist gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation; minimize the negative impact of such gaps on Abbott medical devices and business

• Maintain a working knowledge of all applicable external standards and industry requirements for the biological safety of medical devices (e.g., ISO 10993 Series, ISO 14971, ISO 21726, Regulation (EU) 2017/745, 2023 FDA Guidance on Use of ISO 10993-1, etc.)

• Accountable for timely completion of high-quality technical deliverables

• Perform all activities in compliance with Abbott Quality System

• Mentor junior scientists, chemists, and engineers

• Direct and supervise other technical employees

• Review and approve documents prepared by other Abbott toxicologists

Required Qualifications

• Advanced degree in physiology, pharmacology, toxicology, or other relevant scientific discipline with extensive professional experience:

• PhD with minimum 10 years professional experience in toxicology [or]

• M.Sc. with minimum 14 years professional experience in toxicology

• Diplomate of American Board of Toxicology (DABT) required for Sr. Principal Toxicologist

• Experience in Class III long-term implantable cardiovascular and/or neuromodulation devices

• Solid understanding and extensive experience in applying advanced scientific principles and knowledge in biological safety and toxicology

• Demonstrated successful regulatory submissions and approvals

• Advanced problem-solving and analytical skills and track records

• Handle multiple tasks/projects and manage priorities to meet business timeline

• Work in a fast-paced, highly matrixed, and geographically diverse business environment, collaborate with cross-functional project teams, and exert influence of technical excellence by leading and inclusion

• Technical leadership skills to work within a team as an individual contributor and/or technical supervisor role

• Excellent verbal and written communication with the ability to effectively communicate at multiple levels in the organization

• Strong organizational and follow-up skills, as well as attention to detail

• Computer proficiency using word processors, spreadsheets, project management, and statistical software programs

Preferred Qualifications

• ≥10 years of industry experience as a medical device toxicologist and/or biocompatibility scientist with responsibilities that include toxicological risk assessment

• ≥12 peer reviewed publications in pharmacology, toxicology, or relevant biomedical science discipline

• Has regularly appeared as first or senior author on peer-reviewed publications

• Regularly presents at scientific conferences

• Experience with medical device design, biomaterials, E&L analysis for materials, container-closure systems, manufacturing processes, product life cycle, etc. in the medical device industry per applicable standards

• Demonstrated track record of global regulatory submission approvals (beyond the United States and European Union)

• Experience in GLP toxicity studies in both small and large animal models

• Experience in working in a broader shared service/cross-division business unit model

• Experience in working with technical standard organizations (ISO, AAMI, ASTM, etc.)

• DABT strongly preferred for Principal Toxicologist level (required for Sr. Principal)

Apply Now (https://www.jobs.abbott/us/en)

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 and @AbbottGlobal.

The base pay for this position is $125,300.00 – $250,700.00. 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