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:

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 Senior Biocompatibility Specialist to support our Surgery group.  This role will be based in Raritan, NJ.  An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose: The Sr. Biocompatibility Specialist, will function as a key Toxicology and Biocompatibility team member by energetically supporting the goals of the Toxicology and Biocompatibility department, the company and J&J. Collaborate with associates of diverse technical backgrounds and efficiently manages and oversights testing requests, Toxicology support requests via the Toxicology and LCM mailboxes, and biocompatibility and GLP characterization test results and report receipt for new product development and product life cycle management projects.  The Sr. Biocompatibility Specialist will provide technical input and support to project team members in investigation and experimentation efforts aimed at practical applications of scientific theories or principles.  Assist in the execution of strategies to ensure effective achievement of scientific / technological objectives as defined by project/platform needs.  Document, assist in analysis and interpretation of, verify/quality check, and archive results of research and development activities.

Independently, functions as study sponsor and coordinator by being the primary interface with the contract research organization (CRO) to efficiently coordinate and oversee studies performed at CROs in accordance with global regulatory requirements (ISO, ICH, FDA, etc.) and compliance requirements (GLP, USDA, AAALAC, departmental SOPs, company policies, etc.) under minimal supervision. Reviews protocols and reports to assure compliance with ISO 10993 and its parts to facilitate the approval by the Toxicologist. Maintain requests for department support in a tracker and provide Toxicology workload metrics to management.

This person will be identified as Sr. Archivist, according to the US FDA 21 CFR 58.190. Responsible for oversight of the GLP archive and Test Article Dispensary. 

You will be responsible for:

• Responsible for coordinating test samples for evaluation at internal and external contract laboratories, including calculation of sample numbers required for testing, ensuring proper labelling of samples, and clear communication with research teams providing samples.
• Acts independently as sponsor’s representative for compendial studies. Reviews protocols and reports to assure compliance with ISO 10993 and its parts.
• Ensures that testing meets all international & domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration)-CDRH (Center for Devices and Radiological Health) and GLP (Good Laboratory Practice).
• Requesting and reviewing quotes from CROs for accuracy and consistency.
• Receiving and distributing samples as per GLP and departmental SOPs, maintaining accurate and contemporary tracking records.
• Tracks study progress to ensure timely delivery of data and reports.
• Ensures appropriate documentation is established & maintained in study files to ensure study integrity and timely submission to document archives; verify information in protocols and reports.
• Maintains the Toxicology mailbox as a communication tool for project team requests for Toxicology and biocompatibility support and for record of department activity.
• Maintains proper records of project request and testing to allow for preparation of metrics and reporting to management.
• Reports to management on department activities, non-conformances, and problems related to sample preparation, CRO delays, and overall project flow for planning purposes.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

• A Bachelor’s degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field is required. Master’s Degree highly preferred.
• A minimum of 5 years of experience in industrial research, academic research, or product development experience in a highly regulated healthcare environment is required.
• Experience working with contract research organizations is required.
• Ability to work collaboratively as a team member across various functions in a challenging and changing environment is required.
• Experience working in a regulated environment of medical device safety and supporting product submission and audit to support worldwide market registration is preferred.
• Proven experience with project management skills, managing priorities and time management is required
• Ability to be on-site to execute sample transfers in a timely manner is required.
• Familiarity with medical device product development is required.
• Excellent communication skills to serve as a Toxicology and Biocompatibility spokesperson on scheduling issues (as appropriate) is required.
• Ability to handle multiple tasks and responsibilities and prioritize tasks according to broad project goals is required.
• Basic algebra and geometry skills to perform test article needs calculations for testing requirements is required.
• Self-directed performance in unsupervised environment is required.
• Experience in word processing, project planning, presentation, e-mail business practices and spreadsheet software utilization is required.
• May require up to 10% domestic travel.

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:

Analytical Reasoning, Collaborating, Data Analysis, Detail-Oriented, Drug Discovery Development, EHS Compliance, Good Clinical Practice (GCP), Personal Initiative, Process Control, Process Hazard Analysis (PHA), Process Oriented, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Technical Writing, Technologically Savvy

 

 

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

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)).

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