Primary Toxicologist - MedTech Surgery, Inc.

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 Med Tech, 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.

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Discovery & Pre-Clinical/Clinical Development

Nonclinical Safety

Scientific/Technology

Cincinnati, Ohio, United States of America

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

We are searching for the best talent for a Primary Toxicologist
. This role will work a Flex/Hybrid schedule with 3 days per week on-site and must be based within a commutable distance of Cincinnati, OH. Relocation assistance is available to qualified candidates.

Purpose
:
The Primary Toxicologist will make vital contributions to Front End Innovation, New Product Development, and Life Cycle Management. They are responsible for working with project teams and cross-functional partners on material-centric aspects of our products to ensure patient safety, regulatory compliance, and manufacturing consistency.

You will be responsible for
:

• Evaluating medical device products for safety in compliance with internal procedures, US and international regulations, and ISO 10993.
• Serving as the sponsor for applicable GLP and non-GLP studies, ensuring the studies are of high quality, completed on time, and comply with regulations and procedures.
• Assisting in the design and implementation of biocompatibility evaluations, toxicology risk assessments, and procedures for Ethicon and across Johnson & Johnson Med Tech.
• Reviewing, interpreting, and summarizing toxicological and material chemistry raw data from reports.
• Applying technical expertise to solve complex biocompatibility problems, utilizing ingenuity and business experience.
• Ensuring appropriate documentation is established and maintained to support that the biocompatibility and toxicity testing meets all US and international test requirements per ISO, FDA (US Food and Drug Administration), and GLP (Good Laboratory Practices) regulations.
• Collaborating closely and providing consultative technical expertise to cross-functional partners, including Research & Development, Clinical Affairs, Regulatory Affairs, Surgical R&D, and Supplier Management.

Qualifications / Requirements
:

• Minimum of a Master’s degree in Biology, Chemistry, Biomedical Engineering, or a closely related scientific field required
  . Ph.D. in toxicology or closely related scientific field strongly preferred
  .
• At least of 1-3+ years of professional experience in biocompatibility assessment and evaluation in medical device, pharmaceutical, and/or consumer products required
  .
• Ability to work collaboratively as a team member across various functions in a challenging and changing environment.
• Experience working in a regulated environment of medical device safety and supporting product submission and audit.
• Proven experience with project management skills, leading safety evaluation for multiple projects, managing priorities and time management.
• Skilled verbal and written communication of issues and technical concepts in a clear, concise manner.
• Proactive, self-motivated performer in an unsupervised environment.
• Proficient use…