Methods Development Scientist

PCI Synthesis


August 29, 2014

  • Develop and validate both compendial and noncompendial analytical methods for raw materials, inprocess materials, final product and stability testing.
  • Conduct product degradation studies and maintain the in-house reference standard qualification system
  • Provide technical support for the Quality Control and R&D laboratories, including instrument troubleshooting, routine maintenance and training.
  • Operate, maintain and calibrate analytical instrumentation including HPLC, GC, UV, IR and TOC.
  • Write and follow analytical test methods, validation protocols and reports in compliance with current regulatory requirements and industry standards.
  • Characterize noncompendial standard materials through a variety of testing to establish assay and purity.
  • Maintain, follow, and update Standard Operating Procedures for the Quality Control laboratory.
  • Maintains accurate records.
  • Schedule method development and validation activities.
  • Work with R&D and QC to ensure robust methods are developed and validated that serve the needs of both groups for process development as well as routines QC analysis.
  • Participate in technical meetings with customers to address analytical development issues.

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