Director of Process Development, Life Sciences

Organization
NanoString Technologies
Job Location
530 Fairview Ave
Seattle, WA 98109
Benefits

Medical, dental, 401k, stock options, ESPP

Job Description

NanoString Technologies is currently seeking a highly motivated and experienced manager to join our Life Sciences Product Development team within R&D. This position will be 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. Successful candidates will be independent, multitasking and collaborative in a cross-functional team environment.

Requirements


  • Ph.D. or M.S. 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.

 Additional qualifications may include:

  • 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
About Our Organization

NanoString Technologies is a publicly held provider of life science tools for translational research and molecular diagnostics. The company's technology enables a wide variety of basic research, translational medicine and in vitro diagnostics applications.

NanoString's products are based on a novel digital molecular barcoding technology invented at the Institute for Systems Biology (ISB) in Seattle under direction of Dr. Leroy Hood. The company was founded in 2003 with an exclusive license to develop and market the technology. In 2008, NanoString launched its first commercial instrument system and began international sales operations with its first multiplexed assays for gene expression analysis. In 2010, the company launched new applications for the system to support microRNA analysis and copy number variation detection, and in 2013 launched Prosigna, its first in vitro diagnostic product for prognosis of early stage breast cancer.

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