Sr Manager, IVD Study Operations

  • Illumina
  • US - California - San Diego
  • Mar 26, 2020
Full time Biotech

Job Description

  • This role is part of the IVD Assay Development team and will oversee the laboratory operations for IVD studies. This job requires an understanding and experience developing products under Design Controls and effective management of a team to achieve project goals, as well as interacting with other functions within Product Development, Operations, Clinical and Regulatory to resolve issues and drive execution of project goals.  



    • Manage the planning and execution of multiple IVD studies in coordination with team study leads
    • Takes a lead role and collaborates with others on development programs relevant to long-term objectives and concerns. 
    • Interacts with Quality Affairs to address study design, documentation and CAPA issues
    • Provides direction to senior managers in various areas, groups, and operations.
    • Develops and authorizes the implementation of efficient study execution.  5S and LEAN skills a plus
    • Monitors and evaluates completion of tasks and projects. 
    • Develops budgets for labor, as well as operational and capital expenditures.
    • Collaborates with other top managers to develop and implement company policies.
    • Makes final decisions on administrative or operational matters.
    • Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
    • Makes decisions that have a long-term impact on the overall success of functional, division or company operations.
    • Leads corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.

    Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.



    • Excellent written and verbal communication skills required.
    • Previous experience in clinical laboratories operationalizing multiple studies is a plus
    • Must have previous experience with IVD and/or clinical laboratory (CLIA) testing execution
    • Experience with oncology testing a plus
    • Knowledge of Microsoft Excel and Outlook required
    • Exceptional data analysis and interpretation skills.
    • Excellent communication and team management skills.
    • Must be very detail oriented.
    • Experience with development and validation of regulated products (IVDs)
    • Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work



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