Staff Preclinical Scientist

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

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 West Chester Pennsylvania United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at internal pre-identified candidate for consideration has been identified. However all applications will be considered.

We are searching for the best talent for Staff Preclinical Scientist position.

The Staff Preclinical Scientist functions as a key member of the DS Toxicology Biocompatibility and Preclinical team. This person designs conducts and interprets preclinical in vivo studies that provide evidence of device safety performance and translational relevance while ensuring ethical animal use and regulatory addition the person will apply technical expertise ingenuity business experience and independent judgment to solve preclinical and biological functional safety and performance problems and designs and implement strategies and priorities for evaluations and studies across multiple projects or product portfolios.

You will be responsible for:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• Develops preclinical testing strategies to support product development regulatory submissions and clinical translation.
• Designs in vivo studies that evaluate device safety functionality performance and clinical relevance
• Selects appropriate animal models study endpoints controls and evaluation methods based on intended use and regulatory expectations. Ensures study objectives address key product risks design questions and performance claims
• Acts as study sponsor representative for external CRO and research site activities.
• Prepares study protocols technical justifications and study documentation.
• Oversees study conduct to ensure compliance with applicable regulations GLP requirements and animal welfare standards.
• Analyzes and interprets study data.
• Identifies potential risks failure modes and opportunities for design improvement.
• Stays current with evolving regulatory guidance and and drives continuous improvement in preclinical methodologies and study designs.
• As part of multiple projects partners with R&D Clinical Regulatory Affairs Biocompatibility Toxicology Quality and Marketing teams. Provides consultative direction as well as technical guidance to meet essential requirements necessary to achieve a high-quality product.
• Supports interactions with regulatory authorities by providing scientific rationale and study interpretations.
• Manages prioritization and communicates resource needs and updates in project support to the the PMO and Manager.
• Identifies and evaluates potential risks and drives proactive resolution with team members peers PMO and management.
• May oversee and lead the work of a group of people and supervise direct reports/contractors.
• Provides guidance and mentorship to junior scientists on the team
• Can represent the company in regulatory meetings conferences standards committees or industry consortia
• 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

Qualifications / Requirements:

Education

• A Bachelors or Masters degree or PhD in biology chemistry toxicology microbiology veterinary medicine or a related scientific discipline.
  

Experience and Skills

Required:

• Training in animal research methodologies pathology or histopathology.
• 5-8 years of experience in medical device pharmaceutical CRO or academic research environments.
• Experience designing executing and interpreting in vivo studies.
• Experience working with external research organizations (CROs) and study sites.
• Experience analyzing and interpreting preclinical data and study reports.
• Working knowledge of applicable regulatory requirements and guidance for non-clinical studies.
• Experience authoring scientific protocols study reports technical assessments and regulatory documentation.

Preferred:

• Experience in orthopedic spine trauma sports medicine or other medical device therapeutic areas

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 Internal employees contact AskGS to be directed to your accommodation resource.

#LI- Hybrid

Required Skills:

Preferred Skills:

Biofabrication Biomaterials Biostatistics Coaching Critical Thinking Healthcare Trends Industry Analysis Innovation Medicines and Device Development and Regulation Product Development Quality Standards Raw Materials Research and Development Researching SAP Product Lifecycle Management Technologically Savvy Vendor Selection

The anticipated base pay range for this position is :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

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

This position is eligible to participate in the Companys 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


The following link to general company benefits information MUST also be included in the posting: Please use the following language:

For additional general information on Company benefits please go to: - Experience:

Staff IC