Principal Toxicologist

About this role

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Nonclinical Safety

Job Category: Scientific/Technology

All Job Posting Locations: Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America

Job Description: About Surgery Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a  Principal Toxicologist, Toxicology & Biocompatibility, R&D - MedTech  to support our medical devices business.  This role must be based within a commutable distance of Raritan, NJ  (strongly desired), or  Cincinnati, OH, and will work a Flex / Hybrid schedule with 3 days per week on-site . There is NO remote option.

The Principal Toxicologist, Toxicology & Biocompatibility will serve as a Subject Matter Expert (SME) and a technical lead responsible for Energy, Endomechanical, Biosurgery, Wound Closure & Healing, breast implant Aesthetics & Reconstruction medical devices, and external development opportunities.  The role will involve the assessment and evaluation of novel biosorbable materials and technology platforms to deliver innovative surgical technologies and solutions.  The Principal Toxicologist efficiently executes the biological safety evaluation of medical device products as per internal procedures and global standards and regulations. This person is responsible for planning and execution of in vitro and in vivo biocompatibility evaluations and ensures that products meet the requirements of biological safety according to relevant standards and regulations.  

You will be responsible for: • Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures. • Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products. • Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety. • Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables. • Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion. • Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle. • Can support regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets. • Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools. • Identifies and evaluates potential risks and drives resolution with team members, peers, and management. • Participates in continuous improvement activities and actively participates in shaping processes and procedures. • Responsible for communicating business-related issues or opportunities to next management level. • Responsible for following all company guidelines related to health, safety, and environmental practices as applicable. • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to health, safety, and environmental practices and that all resources needed to do so are available and in good condition, if applicable. • Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures. • Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets. Directly interacts with notified body (TUV, BSI) and regulatory representatives • Performs other duties assigned as needed.  

Qualifications / Requirements : • An advanced degree (MS or Ph.D.) in Toxicology or a related scientific discipline is required.  • A minimum of 6 years in relevant industry in medical

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