Principal Toxicologist MedTEST

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:
R&D Product Development

Job Sub Function:
Materials/Biomaterials Science

Job Category:
Scientific/Technology

All Job Posting Locations:
Raynham, Massachusetts, United States of America

Job Description:

DePuy Synthes is recruiting for a Principal Toxicologist MedTEST, located in Paramount.

JOB SUMMARY

• The Biocompatibility Scientist functions as a key team member by energetically supporting the goals of MedTEST Toxicology & Biocompatibility. The Scientist collaborates with associates of diverse technical backgrounds and efficiently executes the biological safety evaluation of medical device (MD) 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 .

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate DePuy Synthes , procedures and guidelines, this position:

• Evaluates DePuy Synthes medical device products and materials for biological safety per international medical device regulations and standards, GLP (Good Laboratory Practice) guidelines and internal procedures.

• Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for MD 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, Clinical Affairs, Regulatory Affairs, Manufacturing, Quality Engineering, and Supplier Management)

• 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, PMO 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

• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• Bachelor's or master's degree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientific discipline with a minimum of 2 years of industrial experience in biocompatibility evaluation, or PhD with at least 1 year of industrial experience in biocompatibility evaluation

• A minimum 1-2 years of experience in biocompatibility assessment 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.

• 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.

• Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements

• Understanding of manufacturing processes of medical devices is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Ability to work collaboratively as a team member across various functions and disciplines in a challenging and changing environment is required .

• 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.

• Interacts appropriately with all internal and cross-functional partners and demonstrates effective use of conflict resolution skills.

• 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.

ADDITIONAL POSITION REQUIREMENTS

• May participate in organization programs/initiatives outside direct area of responsibility

LOCATION & TRAVEL REQUIREMENTS

• Travel - up to 10%

EXTERNAL INTERACTIONS

• 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 Agencies representatives

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills:
Biofabrication, Biomaterials, Biostatistics, Coaching, Critical Thinking, Global Market, Healthcare Trends, Laboratory Experiments, Medical Affairs, Organizing, Product Development, Research and Development, Researching, Resource Planning, Safety-Oriented, SAP Product Lifecycle Management, Technical Credibility, Technical Writing

The anticipated base pay range for this position is :
Total Base Pay Range 1,17,000.00 - 2,34,000.00 USD Annual

Additional Description for Pay Transparency:
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)). This position is eligible to participate in the Company's long-term incentive program. 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 additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits