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Process Engineer III/IV , Process Development

Job Summary:

The Process Engineer is responsible for developing, implementing, and troubleshooting new methods to be used in manufacturing in support of the release of new products. This individual is responsible for the design and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. In addition, this individual may establish operating equipment specifications to improve manufacturing techniques, in addition to new product design and development.

For this role, we are looking for an individual with a strong background in chemistry development and manufacturing.  This could include background of organic synthesis, oligonucleotide synthesis and purification, fluorophore development, phosphoramidite development, or other related experience.

Essential Functions:

  • Develop methods for the manufacture of chemical compounds for use in nanoString products.
  • Write protocols, experimental summary reports, quality documents and other scientific literature associated with projects
  • Perform and document Risk Assessments
  • Design, document and summarize Verification and Validation studies
  • Draft SOPs, Batch Records, Specifications, and other documentation associated with process transfer to a Manufacturing environment
  • Work cooperatively in a timeline-focused, matrixed, team environment
  • Present data to product/process development teams and management representatives
  • Analyze large, complex data sets using spreadsheets and/or other data analysis packages

Requirements:

  • PhD or MS in Chemistry
  • Minimum of 10 years of industry experience in product development or 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
  • Experience with life science research tools process development
  • Experience working with RNA/DNA/Protein/Antibody assays and protocols, including bioconjugation chemistries and biomolecule purification methods
  • Experience with oligonucleotide synthesis or HPLC method development preferred
  • Comfort working on robotics 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 and record keeping abilities
  • Excellent analytical skills and familiarity with statistical analysis software such as JMP, Minitab, R, etc.
  • Familiarity with ISO 13485 or working within QSR environments preferred
  • Experience in Risk Management and performing Risk Analysis  e.g. FMEAs preferred
  • Comfortable working within electronic quality management systems (EQMS) e.g. MasterControl preferred

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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