Johnson & Johnson Careers

Scientist, Toxicology & Biocompatibility

Cincinnati, Ohio
R&D


Job Description

Requisition ID: 8925180415

Ethicon Endosurgery of Johnson & Johnson, is recruiting for a Scientist, Toxicology & Biocompatibility, to be located in Cincinnati, OH or Somerville, NJ.


The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.


The Scientist, Toxicology & Biocompatibility is responsible for evaluation of medical device (MD) product and combination products for safety as per US and internal procedures and as per the ISO 10993 Standard series.  Assisting in the design and implementation of test systems and procedures for biocompatibility testing for JNJ MD materials and products. Ensuring appropriate documentation is established and maintained. Ensuring that testing meets all international and 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). Overseeing, designing, implementing, and analyzing testing systems, procedures and test results for biocompatibility / toxicology evaluation for all JNJ MD materials & products. Review, interpret, and summarize raw data from reports and support coordination of central documentation procedures required for reports. Apply technical expertise to solve complex biocompatibility problems, utilizing ingenuity, business experience and independent judgment. Interact closely and provide consultative direction and technical expertise to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D and Supplier Management within JNJ MD. This person will also be responsible for contribution to Preclinical Strategy documents, initiation of material characterization studies, in vitro and in vivo study design and final toxicological and biocompatibility reports where necessary to support JNJ medical device products for registration as their expertise allows. 

The Scientist, will function as a key team member by energetically supporting the goals of the Preclinical Center of Excellence (COE) and JNJ. Collaborate with associates of diverse technical backgrounds and efficiently execute evaluations, testing, reporting for product development and product life cycle management, including biocompatibility and product characterization.  The Scientist will provide technical input and support to project team members in investigation and experimentation efforts aimed at practical applications of scientific theories or principles. This person will provide experience and knowledge of product safety data and procedures to support on-site and off-site Regulatory Authority audits to support product, which may be sold in various worldwide markets.


The Scientist is responsible for serving as the sponsor representative for GLP/non-GLP biocompatibility studies at a CRO or Ethicon in accordance with current global regulatory and compliance requirements under minimal supervision. The associate will work with the project coordinator to ensure high quality studies are completed on time with the project team requirements and are compliant to internal and external procedural requirements.

Position Duties & Responsibilities:

  • Design and implement testing systems and procedures for biocompatibility testing for JNJ MD materials and products
  • Ensure appropriate documentation is established & maintained
  • Ensure 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) law
  • Oversee, design, implement, and analyze test systems, procedures and test results for biocompatibility evaluation for JNJ MD materials and products 
  • Summarizing final contract lab reports and supports coordination of central documentation procedures required for product submission reports
  • Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety
  • Interact closely with and provide consultative direction to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D, and Supplier Management within JNJ MD
  • Support on-site and off-site Regulatory Authority audits to support product that may be sold in various worldwide markets.
  • Maintain a collaborative spirit of the work environment that is both professional and ensures the integrity of others as partners and team members who uphold the Johnson and Johnson Credo in everything that is driven towards a potentially marketed product


Qualifications
  • Minimum of a Bachelor’s degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field is required
  • A minimum of 5 years of experience in biocompatibility assessment and evaluation in a medical device, pharmaceutical, and/or consumer product company 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 is required; support for worldwide market registration is preferred
  • Knowledge of biocompatibility assessment for medical devices and previous knowledge of how to conduct and assist in the interpretation of in vivo and in vitro studies is preferred
  • Proven experience with project management skills, leading safety evaluation for multiple projects, managing priorities and time management is required
  • Familiarity with medical device product development is preferred
  • Communication of issues and concepts in a clear, concise manner is required
  • Self-directed performance in unsupervised environment is required
  • Experienced use of Microsoft Office (word processing, project planning, presentation, e-mail and spreadsheets) is required
  • This position will be based in Cincinnati, OH or Somerville, NJ,
     and may require up to 10% domestic travel


Primary Location
United States-Ohio-Cincinnati
Other Locations
North America-United States-New Jersey-Somerville
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
R&D
Requisition ID
8925180415