Johnson & Johnson Careers
Staff Scientist, Toxicology & Biocompatibility
Requisition ID: 8636180801
Johnson & Johnson Medical Device Companies produce a broad range of innovative products and solutions used primarily by health care professionals in the fields of Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products. As the most comprehensive devices business in the world, Johnson & Johnson Medical Devices is best suited to serve evolving customer needs, train more surgeons to improve standards of care, and treat more patients globally as access expands. Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years.
The Staff 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 Staff 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 chemical characterization. They 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 Staff 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.
- 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
- A Bachelor’s degree in biology, chemistry, microbiology, biomedical engineering or a related scientific field is required
- A minimum of 10 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
- This position will be based in Raynham, MA and may require up to 10% domestic travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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