Principal Toxicologist

Johnson & Johnson; Cincinnati (OH); Hybrid; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Toxicologist in MedTech, based near Cincinnati, OH, with a strong background in toxicology and biocompatibility for medical devices. This role requires on-site presence 3 days per week in a hybrid arrangement, with no remote option.

You will guide biocompatibility strategies, support regulatory interactions, and mentor teams across R&D and regulatory functions. The ideal candidate holds an advanced degree with extensive experience in ISO standards and

Qualifications

• MS or PhD in Toxicology or a related scientific discipline is required.
• A minimum of 6 years in relevant industry in medical devices is required.
• A minimum of 8-10 years of experience in toxicology and biocompatibility assessments is required.
• Experience in regulatory submissions and audits is required; support for worldwide markets preferred.
• Familiarity with ISO 13485, ISO 10993, ISO 14971 and design control systems is required.
• Travel – up to 10%.

Responsibilities

• Evaluates medical device products and materials for biological safety per international medical device regulations and GLP guidelines.
• Designs, initiates, coordinates, and interprets laboratory biocompatibility and toxicology studies.
• Applies technical expertise to solve biocompatibility issues per ISO 10993 and regulatory requirements.
• Coordinates with cross-functional teams to plan and execute required testing and deliverables.
• Interacts with internal and external stakeholders and provides technical guidance on medical devices across the lifecycle.
• Supports regulatory/notified body requests as part of audits and submissions.

Skills

Toxicology

Biocompatibility

Medical devices

Regulatory affairs

Leadership

Project management

Communication

Education

MS or PhD in Toxicology or related discipline

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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 devices is required.
• A minimum of 8-10 years of experience in toxicology and biocompatibility assessments and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry is required. Experience in medical devices is strongly preferred.
• Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
• Experience in absorbable biomaterials for implantable medical devices, including experience in medical device material degradation and toxicokinetics, is required.
• Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements is required
• Familiarity with relevant industry standards, i.e., ISO 13485, ISO 10993, ISO 14971, and design control systems is required
• Knowledge of laboratory animal care & use practices is strongly preferred
• Understanding of manufacturing processes of medical devices is strongly preferred.

Required And Preferred Skills

• Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required. Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.
• Demonstrates technical leadership and mentorship.
• Demonstrates behavior qualities including confidence, transparency, integrity, innovation, passion, patience, and tenacity.
• Excellent written and verbal communication skills. Depending on location, local language skills are preferrable.
• Proactive and self-directed performance in an unsupervised environment and tenacity to overcome major obstacles are required.
• Able to drive problem resolution efficiently and proactively through effective use of analytical and problem-solving skills.
• May participate in organization programs/initiatives outside direct area of responsibility
• Travel – up to 10%

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills:

Clinical Data Management, Critical Thinking, Drug Discovery Development, EHS Compliance, Emergency Planning, Organizing, Performance Measurement, Presentation Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00