Program Manager , Assay

Organization
Cepheid - US
Job Location
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Sunnyvale, CA 94089
Job Description

The Program Manager of Assay will be responsible for the overall direction, coordination, implementation, execution, control and completion of specific in vitro diagnostic assay programs within a medical device and/or molecular in-vitro diagnostic company while ensuring consistency with company strategy, commitments and goals.

 

This position is contract in nature and has an estimated duration of 12 months.

 

 

  • Lead the planning and implementation of multiple assay development projects and programs
  • Facilitate the definition of project scope, goals and deliverables
  • Define project tasks and resource requirements
  • Develop full scale project plans
  • Manage Design History File. Meeting Minutes; Risk Management Files, and project documentation
  • Manage project resource allocation
  • Plan and schedule project timelines
  • Track project deliverables using appropriate tools
  • Provide direction and support to project teams
  • Constantly monitor and report on progress of the project to all stakeholders
  • Present reports defining program progress, problems and solutions
  • Implement and manage project changes and interventions to achieve project outputs
  • Program evaluations and assessment of results

 

 

Bachelor's degree is required. Bioengineering, Biomedical engineering, and/or a technical discipline is preferred

  • 5+ years of direct work experience in a program management capacity, including all aspects of clinical development, plan execution and product launch
  • Proven experience in launching multiple products from concept to commercialization stage
  • Superior knowledge of both theoretical and practical aspects of project management
  • Excellent knowledge of project management techniques and tools
  • Working knowledge of quality documentation management systems
  • Direct work experience in project/program management capacity
  • Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003
  • Proven experience in people management
  • Proven experience in risk management
  • Proficient in project management software
  • Proven understanding of assay product development lifecycle

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