Analytical Assay Development Manager

Cambridge, UK

We are currently seeking qualified candidates for an Analytical Assay Development Manager in Cambridge, UK. The successful candidate will be responsible for developing, validating, and optimizing MS assays and associated Breath Biopsy methods, from early pre-clinical stages to commercial product development, targeting both research and In-Vitro Diagnostic (IVD) use.

Areas of responsibility:

  • Provide technical leadership for MS assay development, consistent with the overall product development plan
  • Lead and support the execution of validation studies for new assays/methods and lead transfer of those new assays/methods into the Owlstone Breath Biopsy Laboratory
  • Supervise development of verification protocols under Design Control, with appropriate collaboration and coordination with the R&D team
  • Actively participate in, and seek input from, cross-functional teams (including algorithm, software, clinical, manufacturing, quality, and regulatory teams) to ensure company-wide alignment with the assay development work flow
  • Create validation documentation that meets standards required for inclusion in regulatory filings

    Requirements:

  • In-depth knowledge of mass spectrometry used in a commercial test setting
  • Strong demonstrated ability to lead and manage scientists/research associates
  • Experience with regulated LC/GC MS assay development, including transfer, verification, and validation activities necessary for research and diagnostic product commercialization
  • Experience developing and launching MS-based assays compliant with FDA or CE-IVD requirements is preferred
  • Excellent technical scientific writing, communication, and organizational skills
     

    The successful candidate:

  • Will be able to demonstrate hands-on team leadership skills
  • Must be self-directed, organized and conscientious
  • Will be proficient in executing design transfers and in-process quality checks
  • Will have the ability to solve complex technical problems
  • Must have demonstrated the ability to work under pressure and with short deadlines to accomplish objectives
  • Will communicate effectively with technical and non-technical personnel
  • Will think strategically when planning, managing teams, and managing processes

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.

Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% - unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.


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