James Klancke

Senior Analytical Development Consultant


Mr. Klancke is an Analytical Executive with over 30 years of industry expertise in analytical method development and validation, analysis, and stability of pharmaceuticals in a GMP environment. He has expertise in all phases from drug concept through commercialization and has demonstrated leadership and management of large laboratory and technical teams. He also has experience in the development and validation of dissolution methods.

Jim has a proven ability to work effectively and meet or exceed expectations of internal and external customers leading to the launch of numerous products.

He applies a high level of proficiency in experimental design, data assessments, specification development, and risk assessment and mitigation in facilitating successful product development.

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Core Competencies

  • Stability Testing
  • Experimental Design/DOE
  • Phase I - Phase IV
  • Characterization
  • Method Development
  • Validation
  • Buccal Absorption
  • Pediatric Formulation