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Manager Reagent Systems San Jose United States,  

Becton Dickinson (company)


Posted on : 22 October 2017

Project Description

Job Description

The Manager, Reagent Systems is responsible for development and post launch support of the reagent assays for clinical Flow Cytometry systems.

Primary duties include the following:

  • Manage the Reagent Systems team. Responsible for building and leading a coordinated and collaborative R&D team to facilitate efficient resource utilization and flexibility to respond to business growth opportunities.
  • Maintain strong understanding of state-of-the-art science and technology development in the industry.
  • Participate in clinical product development programs for the effective introduction of new products, consistent with the strategic plan.
  • Lead the team to perform benchmarking studies with competitor assays and find improvement opportunities.
  • Deliver clinical projects on schedule and within specification. Work with leadership team members and product development teams to improve time to market by reducing product development life cycle and improving the product development process.
  • Prepare and oversee the preparation of technical reports, summaries, protocols, and analyses of R&D projects.
  • Plan/participate in the sustaining projects, lead troubleshooting and risk assessment activities.
  • Participate in interactions with regulatory agencies. Provide technical input into safety and regulatory interactions. Lead the team to provide R&D support of WW regulatory product registrations.
  • Work on issues where analysis of situation or data requires review of relevant factors. Exercise judgment within defined procedures and policies to determine appropriate action.
  • Effectively coordinate with other functional areas associated with the R&D activities, including Legal, Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, Business Development, etc.
  • Work with Quality on streamlining processes related to PIRs and CAPAs to reach a rapid and effective conclusion.

Locations

San Jose, California

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