Director, Process Development in Seattle, WA

$200K - $250K(Ladders Estimates)

NanoString Technologies   •  

Seattle, WA 98160

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 50 days ago

The Director, Process Development is responsible for management of Process Development for new life science products and product lines. In addition, the candidate will also be responsible for technology transfer into Manufacturing.

Essential Functions:

  • Management of Process Development for new life science products and product lines
  • Responsible for technology transfer into Manufacturing

Qualifications and Requirements (Education, Experience, Specific Skills):

  • PhD or MS in related life science discipline
  • Minimum of 10 years of industry experience in process development and technology transfer
  • Understanding of product development lifecycle (development, V&V, design control, design transfer, sustaining support)
  • Extensive experience with Design-Of-Experiments (DOE) and associated analysis
  • Detailed understanding of process capability measurement and analysis
  • Experience with test method development and capability analysis
  • Experience in Risk Management and performing Risk Analysis e.g. FMEAs
  • Team-forming experience and ability to drive new processes and capabilities
  • Experience with life science research tools process development
  • Comfort working with robotic platforms such as the nCounter instrument or liquid handing systems
  • Experience with ISO and FDA process development standards and principles including definition of critical process parameters and critical quality attributes
  • Excellent technical writing skills
  • Excellent analytical skills and familiarity with statistical analysis software such as JMP, Minitab, R, etc.
  • Experience working with RNA/DNA assays and protocols
  • Experience with protein or antibody conjugation development and manufacturing
  • Practical experience with protein/antibody conjugation equipment used in a manufacturing environment
  • Familiarity with ISO 13485 or working within GMP/QSR environments
  • Experience with GMP production and batch record review
  • Comfortable working within electronic quality management systems (EQMS) e.g. MasterControl
  • Candidates with less years of experience will be considered if experience in closely aligned area


Valid Through: 2019-10-21