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Senior Manager, Toxicology & Biocompatibility
Requisition ID: 0898180508
Ethicon Endosurgery of Johnson & Johnson, is recruiting for a Senior Manager, Toxicology & Biocompatibility, to be located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic wound repair 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.
The Senior Manager, Toxicology & Biocompatibility will Lead the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across the Ethicon franchise of products. This individual works closely with Preclinical Functionality leadership to understand project requirements, priorities and timelines to effectively assign resources for preclinical safety assessments. The individual interfaces with key internal stakeholders and regulatory authorities to deliver robust preclinical assessments that meet regulatory approval and ensures patient safety. This role serves as the member of the Toxicology and Biocompatibility leadership team in developing an industry leading organizational team in developing an industry leading toxicology and biocompatibility organization focused on innovation and patient safety.
POSITION DUTIES & RESPONSIBILITIES:
- Manage direct staff conducting toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety across the Ethicon franchise
- Partner with preclinical functionality leaders to develop robust biocompatibility and preclinical strategies and evidence generation strategies to meet NPD goals and ensure patient safety
- Develop and implement biocompatibility and toxicology resourcing strategy to update support of business unit needs
- Conduct safety assessment for new product development and provide solutions for evaluation of safety risk for manufacturing and life cycle management challenges
- Work with Preclinical Operations, Advanced Modeling and other functional leaders to execute product design evaluations required for product approval and patient safety across the medical device sector
- Oversee, manage and prioritize resources to conduct biocompatibility and assessments for projects across the Ethicon franchise. Provide scientific input and rationale for high potential projects to effectively direct and utilize resources.
- Partner with Preclinical Functionality and Franchise leaders to develop preclinical project budgets to address patient safety assessments. Work within the Integrated Strategic Services Team and across company sectors to develop biocompatibility and toxicology models.
- Drive interactions with project teams early in the process to identify potential risks to projects and develop robust Biological Evaluation Matrix
- Interface closely with the R&D site leadership to ensure business needs are met for life cycle management and materials teams and for Product Stewardship challenges toxicology
- Talent Development: develop and strengthen the toxicology and biocompatibility talent pipeline. Ensure the right people are in the right roles across the toxicology and biocompatibility scientific ladder.
- Maintaining 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 Master’s Degree in Toxicology, Biology, or a related scientific field, with a minimum of 12 years of experience in biocompatibility and/or toxicology in a medical device, pharmaceutical, and/or consumer product industry is required. A Doctoral degree (e.g. PhD, PharmD, or equivalent degree) with 10 years of experience in the same related fields is preferred.
- A minimum of 8 years’ of proven experience managing a group, that includes senior scientific staff (i.e. PhD or equivalent level staff), to deliver on complex scientific assessments, is required with a Master’s degree. A minimum of 5 years’ experience managing the same level staff is required with a Doctoral degree.
- Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement and support the transformation of a function is required
- Experience with leading multiple projects, managing priorities and resource management is required
- Board Certification in ATS, DABT, DACVP, or related certification is preferred but not required
- Demonstrated working knowledge and expertise in conducting toxicological safety assessments for chemicals and transforming risk assessment in to regulatory submission documents is required
- Ability to work collaboratively as a team member across various functions in a challenging and changing environment is required
- Demonstrated knowledge of working within a highly regulated industry and strong knowledge of quality systems management (e.g. ISO 13485, EU MDD and 21 CFR 820) to avoid and resolve issues with CAPA, product recalls and external audits is required
- Working knowledge and understanding of medical device product development as guided by ISO 10993, ISO 14971 and analytical testing application for product extractables and leachables is required
- This position will be located in Cincinnati, OH and may require up to 10% travel
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