Assay Development Project Manager

Cambridge, UK

The Assay Development Project Manager is responsible for leading and managing projects to develop assays using Owlstone Medical’s Breath Biopsy platform for Research Use Only (RUO) or In Vitro Diagnostic (IVD) use.   

Key Tasks / Accountabilities

  • Working with other senior staff to evaluate and select future applications for Breath Biopsy in research and diagnostic markets
  • Leading multidisciplinary project teams to develop Breath Biopsy assays from concept through to commercialization, with accountability for project delivery
  • Ensuring that your projects have clear goals and milestones that are aligned to those of the business, and supporting project team members to set and achieve their own goals and outputs accordingly
  • Creating assay development project plans through all stages of development, supported by key technical, operational, quality and regulatory staff
  • Managing project budgets, schedules, resources and risks
  • Regularly communicating project plans, resource requirements, status, risks and mitigations to senior management

Competencies & Requirements of the role

Essential

  • A track record of taking RUO and / or IVD assays through multiple stages of development, to commercial launch
  • The ability to lead and manage technically complex projects with multi-disciplinary project teams
  • Strong communication and leadership skills
  • Adaptability, persistence and a willingness to embrace change

Desirable

  • Experience developing and launching mass-spectrometry-based assays
  • Experience with metabolomic assays for research or clinical use
     

Person Specification 

Education & Training 

  • A degree in biological or physical sciences is highly desirable

Experience / Knowledge      

  • Practical understanding and working knowledge of project management best practice, tools and techniques
  • A good understanding of the quality-assurance and regulatory frameworks applicable to RUO and IVD assays, including FDA and CE-IVD requirements,  is highly desirable
  • An understanding of markets, customers and competitive landscapes for research-use and diagnostic assays is desirable


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