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Senior Principal R&D Scientist- CDx

4 months ago

Newcastle Upon Tyne, United Kingdom Danaher Full time

Leica Biosystemsâ mission of âAdvancing Cancer Diagnostics, Improving Livesâ is at the heart of our corporate culture. Weâre a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, youâre helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, weâre working at the pace of change to improve patient lives with diagnostic tools that address the worldâs biggest health challenges. 

The Senior Principal Research and Development Scientist is critical to the development of immunochemistry and growth of complex advanced staining assays to drive clinical content. Providing strategic direction to inform our R&D efforts, driving innovation and creation of novel diagnostics assays and platforms to support precision medicine initiatives, positioning Leica Biosystems (LBS) as a leading-edge cancer diagnostics pharma partner.

This position is part of the Research and Development (R&D) team located onsite in Newcastle, UK at our Advanced Assays Centre of innovation and will be an on-site, position.  

If you thrive in an innovative research and development environment and want to be part of a world-class R&D organization, read on.

In this role, you will have the opportunity to:

Collaborate with LBSâs 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 LBSâs 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. 

The essential requirements of the job include:

  • Significant experience working within CDx (Companion Diagnostics)
  • 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
  • Playing a lead role in patent intellectual property practices. 
  • 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.
  • Playing a lead role in patent intellectual property practices. 

It would be a plus if you also possess previous experience in:

  • CLIA laboratory
  • Troubleshooting complex scientific / technical problems
  • Driving change and supporting strategic growth
  • Scientific achievement demonstrated by peer reviewed publications and patents.

 

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.