Senior Manager of Biocompatibility
Senior Manager of Biocompatibility
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1 Vacancy
Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Enterprise ManagementJob Sub Function:
R&D ManagementJob Category:
People LeaderAll Job Posting Locations:
Cincinnati Ohio United States of AmericaJob Description:
We are searching for the best talent to join our MedTech Surgery team as a Senior Manager of Biocompatibility to support our Surgery portfolio of energy endomechanical and robotics products. This position will be based in Cincinnati OH.
Purpose: The Senior Manager of Biocompatibility will lead the development and execution of toxicology and biocompatibility evaluations for surgical medical device products. This role will be pivotal in expanding program capabilities to accelerate innovation ensuring product safety and regulatory compliance and guiding cross-functional teams in the integration of toxicology/biocompatibility insights into product development. This position will report directly to the Director of Materials Science J&J MedTech.
In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:
- Strategic Leadership: Develop and implement robust toxicology and biocompatibility strategies aligned with business goals. Responsible for managing operational aspects of their team (e.g. workflow performance and compliance) as well as ensuring achievement of team goals within established timelines and budgets.
- Innovation: Develop enhanced capabilities leveraging new technology and process improvements to advance and accelerate chemical characterization and biocompatibility assessments. Identify and implement new ways of working to accelerate speed to market and harmonize knowledge and processes across J&J MedTech.
- Risk Assessment: Oversee the design and interpretation of toxicological studies including in vitro and in vivo assessments to identify potential risks associated with products.
- Cross-Functional Collaboration: Work closely with R&D Regulatory Affairs and supply chain partners to integrate toxicology insights into product development processes. Collaborates with multiple R&D departments to develop and manage financial goals establish and implement business strategy and analyze staffing needs to deliver innovative product development solutions.
- Scientific Communication: Prepare and present reports presentations and regulatory submissions to internal stakeholders and regulatory bodies clearly communicating complex scientific data.
- Industry Engagement: Keep abreast of current trends and advancements in toxicology/biocompatibility science representing the company in relevant industry forums and conferences.
Education and Required Experience:
- Minimum of a Masters Degree in Toxicology Pharmacology Biological Sciences or a related field required. PhD is preferred.
- Minimum of 8 years of experience in toxicology/biocompatibility with a strong focus in the pharmaceutical or medical device industries.
- Board Certification in ATS DABT or related certification is preferred but not required.
- Demonstrated working knowledge and expertise in conducting toxicological safety assessments for chemicals and transforming risk assessment into regulatory submission documents.
- A proven track record of interaction with US FDA and other OUS regulatory authorities on implementation of ISO 10993 ISO 14971 and ISO 13485.
- Demonstrated knowledge of working within a highly regulated industry and strong knowledge of quality systems management (e.g. ISO 13485 EU MDR and 21 CFR 820) to avoid and resolve issues with CAPA product recalls and external audits.
- Minimum of 3 years of experience in leading teams of technical subject matter experts shaping operational changes and navigating complexity to build new capabilities
- Extensive knowledge of regulatory requirements and guidelines related to toxicology and biocompatibility.
- Strong problem-solving skills and the ability to analyze complex data to inform decision-making.
- Exceptional communication skills both written and verbal with experience presenting scientific data to various audiences.
Other:
- This position is based in Cincinnati OH and requires up to 10% 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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Required Experience:
Senior Manager
Employment Type
Full-Time
