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Leica Biosystems - We‘re Hiring in Massachusetts!
Leica Biosystems is one of the fastest growing diagnostics companies in the world. Our rapid growth in companion, immunohistochemistry cancer diagnostics and pharmacuetical partnerships, requires the addition of energetic and knowledgable scientists to our development and commercial teams.
We are recruiting Companion Diagnostics Project Leaders who shall be responsible for the development, validation, optimisation and implementation of in vitro and companion diagnostic processes that will deliver class III IVD devices to the market within agreed timelines and budgets from the Danvers facility.
The successful applicant will:
Provide advanced project and process management expertise that helps drive assigned Pharma and companion diagnostics projects to successful outcomes
Provide in vitro diagnostics development throughout the whole product development cycle to Pharma / Biotech companies
Contribute to project documentation in line with process, including preparation of all documentation for dealings with regulatory authorities (e.g. Pre-IDE, Ide, PMAS Submissions)
Work together with the Pharma Partnership team to manage, coordinate and oversee the full R & D aspects of CDx programmes with external collaborators within agreed timelines, budget and resources.
Provide leadership to a team, including performance management, development and monitoring of output.