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Company Name:
Depuy Orthopaedics. Inc. (6029)
West Chester, PA, US
Senior Director - Biocompatibility
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Director - Biocompatibility to be located in West Chester, PA, Warsaw, IN, or Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Director - Biocompatibility leads the Global Biocompatibility function providing strategic and tactical direction in support of the business objectives. Influence the company's strategic and tactical directions and financial results globally through the application of technical leadership, knowledge and expertise. Create and lead a functional team to meet the DePuy Synthes needs in the area of biocompatibility. Develops company strategies for the functional area. Identify and implement training strategies to assure team technical competence in biocompatibility.
The Senior Director - Biocompatibility provides in-depth technical support for new and existing products. Address knowledge gaps and resource needs for the Biocompatibility organization through succession management and talent acquisition. Provides direction on quality and compliance requirements with respect to biocompatibility that satisfy global regulatory requirements. Provides strategic leadership role in providing technical support for process changes. Provides resources to participate in due diligence and on-site technical assessments related to potential acquisitions
The Senior Director - Biocompatibility develops and manages programs to assess product and process changes to determine potential impact to product biocompatibility and develop technical rationales and/or testing strategies. Oversee the development of product cleanliness requirements and monitoring programs. Leads the development of toxicology/biocompatibility health-based risk assessment strategies. Actively interact with the internal and external scientific community to maintain state of the art knowledge. Manages biological safety assessments to determine if previous biocompatibility testing has been conducted on similar devices or components of new device(s); also conduct literature searches as needed.
The Senior Director - Biocompatibility develops systematic programs for Biocompatibility Testing Strategies based on materials list, manufacturing processes, changes to device. Identifies areas for improvement to biocompatibility processes and implements as needed. Works closely with business partners in Regulatory Affairs, Operations R&D and Quality. Devises new approaches to problems encountered.
To be considered for the role a minimum of a Bachelor's degree in a biological science (e.g., Biology, Microbiology, Biochemistry, Molecular Biology); and 15 or more years of related experience and/or training; or Master's degree and 10 or more years of experience; or PhD and 5 years of experience; equivalent combination of education and experience. Experience in the medical device industry would be an additional asset.
Demonstrated ability to influence cross-functional and upper management to impact decision-making is required. Willingness to "have an opinion" backed up by insight and the confidence to influence key stakeholders in meetings and one to one basis is required. Ability to think analytically to understand complex or ambiguous problems or issues and communicate solutions/conclusions clearly and concisely is required. Three years of management experience in supervising direct reports is required.
Experience as a Study Director preferred. Experience in completing risk assessments preferred. DABT preferred. Experience with the application of ISO 10993 in an industry setting is strongly preferred. Good written and oral English communication skills. Good documentation and excellent communication skills are required, as is the ability to be a team player with customer focus, flexibility, and a strong goal to deliver.
This position will be located in to be located in West Chester, PA, Warsaw, IN, or Raynham, MA and requires up to 15% travel including potential international travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:
North America-US-Pennsylvania-West Chester
Other Locations:
North America-US-Massachusetts-Raynham, North America-US-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)
Yes, 10 % of the Time
Job Function:
Quality (Generalist)
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