The Johnson and Johnson Medical Device Preclinical Center of Excellence is recruiting for a Medical Device Toxicologist. The position will be located in Somerville, NJ. The successful candidate will design and implement testing programs for Toxicology/Biocompatibility evaluation and carefully review existing data in order to conduct Toxicology/Biocompatibility Risk Assessments for J&J Biosurgery and Wound Closure devices, drugs, and combination products.
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. 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 a key member of the preclinical toxicology group, the associate will work with a diverse team of subject matter experts charged with the responsibly to develop, execute and represent state of the art multidisciplinary Medical Device safety evaluation strategies. He/she will bridge any and all internal or external organizational boundaries to ensure seamless safety coverage for the patients, doctors and other users of our medical devices. The candidate must possess the communication and people skills to represent the department within the organization and externally at scientific meetings, regulatory presentations and international standards organizations.
The ideal candidate for this position will have a professional research-based degree (PhD/equivalent) in the life sciences, with a documented track record of effective team contributions. The ideal candidate will have at least one year of relevant industrial toxicology experience and have at least a conversational understanding of ISO 10993 and related domestic and international guidance documents.
Principal duties and responsibilities include but are not limited to:
• Working with project teams, prepare biological evaluation strategies, execute testing and risk assessment activities as needed
• Partner with Regulatory Affairs, Supplier Management, Life Cycle Materials& Project Teams for regulatory submissions supporting pre-clinical safety
• Serve as Sponsor Representative and Study Monitor for biocompatibility studies placed at contract laboratories
• Summarize, analyze, and interpret raw data from test reports.
• Effectively communicate with laboratories in oral & written form regarding test requirements, issues, deviations & special requests
• Participate in test study design as necessary
• Review & approve or modify protocols & study proposals for contract labs
• Perform literature searches as appropriate for material submissions
• Communicate with internal and external experts to assist in resolution of biocompatibility challenges
• Support NPD Development and Design Change Teams in material selection
• Pre-clinical support for medical products using in vitro & in vivo models
• Assist in maintenance of corporate biocompatibility database
• Apply biocompatibility standards to the evaluation of Ethicon devices
• Ensure that testing meets all international & domestic test requirements according to ISO (International Standards Organization), FDA (Food & Drug Administration)-CDRH (Center for Devices & Radiological Health), ICH (International Conference on Harmonization) & GLP (Good Laboratory Practice) guidelines
• Collaborate with associates of diverse technical backgrounds (chemistry, pathology, statistics, physiology, materials science, engineering, regulatory and veterinary surgery) to achieve desired project outcomes; interact closely & providing consultative direction to R&D, Clinical Affairs, Regulatory Affairs & Supplier Management, reviewing regulatory submissions and providing input.
• PhD or equivalent degree in Toxicology, Biology, or a related field is required.
• At least one year of relevant Medical Device toxicology experience with a documented track record of effective team contributions is required.
• Knowledge of in vivo and in vitro models of safety assessment is required.
• Knowledge of risk assessment process for leachable chemicals from medical devices is required.
• Excellent skills as a team member/participant.
• Knowledge of relevant international standards is preferred.
• Up to 10% travel required
United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
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