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Manager, Manufacturing Development (Life Sciences)

Job Summary:

NanoString Technologies is seeking an experienced Molecular Biologist and Manager who will report to the Director, Manufacturing Development.  This role will be responsible for supporting both transfer of new Life Sciences products and processes into Manufacturing, as well as sustaining existing ones.  Sustaining activities may include methods development, optimization and scale-up, material change qualification and troubleshooting.  Expert level of technical knowledge in molecular techniques, recent bench experience, the ability to work collaboratively in a team environment and a prior managerial role are critical for success in this position.

Essential Functions:

  • Represent Manufacturing Development interests on Product Development Project teams.  Define and execute activities required to support transfer of new products and processes to Manufacturing
  • Represent Manufacturing Development interests on Consumables and Reagents Sustaining team.  Define and execute activities required to realize assigned projects
  • Direct team of Research Associates to support attainment of Life Sciences Manufacturing Development objectives
  • Prepare study protocols and reports, risk assessments and other Quality documents
  • Work cooperatively in a timeline-focused team environment
  • Other roles as assigned

Requirements:

  • Minimum of 3 years of experience managing a technical staff
  • Ph.D. or M.S. in related life science discipline
  • Minimum of 8 years of bench experience, preferably with at least 3 years in a production, GMP, GLP or CLIA lab setting
  • Knowledge of ISO-13485, ISO-14971 and/or QSR 21 CFR 820
  • Prior experience applying Design of Experiments (DOE) methodology and familiarity with statistical analysis software (JMP preferred)
  • Understanding of product development lifecycle (particularly design transfer and sustaining support)
  • Prior experience in CAPA and Non-conforming Materials investigations and Root Cause Analysis
  • Excellent analytical skills, strong technical writing capabilities and exquisite attention to detail
  • Experience with MasterControl or other EQMS system'

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