Associate Director/Director of Analytical Development

Job Description

Responsible for leading the analytical development activities in a virtual CMC environment.

Key factors for role

Primary Responsibilities

  • Manages external analytical vendors
  • Reviews and finalizes analytical raw material, in-process, release methods, protocols, reports and stability results
  • Maintains high standards of quality and regulatory compliance
  • Identifies areas of improvement of analytical methods and trouble-shoots analytical problems
  • Provides statistical analysis of analytical results to support stability assessments
  • Prepares and reviews analytical chemistry for the CMC section of drug substance and drug product regulatory submission (INDs, IMPD, Briefing Documents)
  • Interacts with US and/or EU Regulatory as it relates to questions regarding analytical development

Knowledge and Skill Requirements

  • PhD in a science related to Pharmaceutical Analysis with 10+ years working in analytical development in a pharmaceutical or biotechnology environment, experience in a virtual environment a plus
  • Excellent technical knowledge of current drug substance and drug product analytical techniques (HPLC, GC, MS, IR, IC, NMR, XRPD)
  • Method development and validation expertise
  • Ability to perform statistical analysis of analytical results to support stability assessments
  • Knowledge of the most current Regulatory/QA/ICH guidance to ensure that all laboratory work and documentation is completed to the highest quality compliance standards
  • Experience auditing external analytical suppliers working in GMP/GLP environments
  • Familiar with Out of Specification (OOS) investigational procedures and able to conduct them promptly and thoroughly
  • Excellent written and oral skills
  • Strong organizational skill to manage a large volume of analytical documentation in a controlled manner
  • Experienced in representing analytical development on multifunctional teams
  • Management experience overseeing analytical group members working in a team-oriented CMC environment.
  • Experience with electronic submissions a plus.

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