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Analytical Development Chemist

Colorado, United States

I am partnered with an outstanding client who are adding to their team. They are looking to bring on multiple Analytical Development Scientists to support process development and clinical manufacturing activities. This role focuses on developing and improving analytical methods, supporting technology transfer, and ensuring high-quality data for regulatory and manufacturing needs.


Key Responsibilities

  • Perform analytical R&D to support process design, optimization, and clinical trial material production.
  • Develop, validate, and transfer analytical methods using techniques such as HPLC, UPLC, LC/MS, LC/MS/MS, GC/MS, and process chromatography.
  • Author and review analytical procedures, reports, and documentation for regulatory and manufacturing support.
  • Provide analytical expertise to cross-functional R&D teams and assist in troubleshooting laboratory and manufacturing challenges.
  • Participate in batch analysis and release of drug substances and intermediates for clinical and registration programs.

Qualifications

  • PhD or MS in Chemistry with 2+ years of relevant experience, or BS with 6+ years.
  • Hands-on experience with MS, LC/MS, GC/MS, and related analytical technologies.
  • Background in method development, validation, and technology transfer.
  • CDMO/ GMP experience needed

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