Collaborate with LBS’s global Companion Diagnostics (CDx) Business Development and Commercial teams to develop strategies and tactics aimed at realizing the commercial potential of the CDx Advanced Assays and Reagent projects against the highest Environment, Health, and Safety standards.
Lead the technical design, development, growth, and validation of complex companion diagnostic assays, identify emerging technologies and trends in diagnostics to further drive innovation. Leverage and develop R&D capabilities, establish partnerships and the execution of project roadmaps at LBS.
Provide expert technical insights, innovation, and critical thinking in collaboration with a team of highly experienced individuals, to deliver, complex high classification projects from ideation stage to commercially viable products across the portfolio.
Partner with LBS’s clinical affairs, regulatory affairs, and medical/scientific affairs teams to develop capabilities and strategies to efficiently plan and execute studies in support of products requiring FDA 510(k), PMA, or BSI approval. Staying abreast of design control requirements and the evolving regulatory landscape to ensure new product development is compliant with standards (FDA, BSI).
Provide research expertise and guidance, leading a culture of continuous improvement leveraging Danaher Business Systems and setting expectations for high performance across the organization. Recognized as a thought leader, that develops competence in others serving as a technical mentor to the broader R&D team.
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Significant experience working within CDx (Companion Diagnostics)
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Experience working with emerging, innovative products, commercial product development including the transfer of complex feasibility projects into product commercialization, diagnostic techniques such as, immunohistochemistry (IHC) and in situ hybridization (ISH) and fluorescence
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Playing a lead role in patent intellectual property practices.
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Building collaborative partnerships within the Advanced Assay Centre of Excellence and Imaging Leadership teams. Work with business units (Melbourne, Vista, Shanghai, Nussloch & Amsterdam) as well as the Open Innovation team, to assess potential opportunities in the marketplace through building relationships with key opinion leaders.
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Playing a lead role in patent intellectual property practices.
It would be a plus if you also possess previous experience in:
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CLIA laboratory
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Troubleshooting complex scientific / technical problems
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Driving change and supporting strategic growth
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Scientific achievement demonstrated by peer reviewed publications and patents.
Contact Detail:
Leica Biosystems Recruiting Team
