Principal/Sr. Principal Toxicologist

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:

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 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

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 strate