Associate Director, Analytical R&d/ar&d

Catalent

Winchester, KY, US
Fda ich usp ep jp mhra compliance
Analytical method validation and transfer
Oos/oot investigation and root cause analysis
Develop and implement a clear strategic vision for quality control to maximize employee focus and competitive advantage

Job Summary

  • Develop and implement a clear strategic vision for quality control to maximize employee focus and competitive advantage.
  • Oversee the Analytical R&D team for method development, transfers, and validations to support new product pipelines.
  • Ensure all Quality Control systems remain compliant with FDA, ICH, USP, EP, JP, and MHRA regulations.

Matching Summary

Develop and implement a clear strategic vision for quality control to maximize employee focus and competitive advantage.

Skills & Requirements

Must-have

  • FDA ICH USP EP JP MHRA compliance
  • Analytical method validation and transfer
  • OOS/OOT investigation and root cause analysis
  • CAPA implementation and oversight
  • IQ/OQ/PQ scheduling and management
  • CFR Part 11 data integrity adherence
  • DEA controlled substance handling

Nice-to-have

  • Strategic vision for quality control
  • Competitive advantage development
  • Cross-functional collaboration with formulation
  • Employee training program administration
  • Regulatory dossier submission support

Key Requirements

  • Bachelor's degree in Chemistry or Related Field
  • 8 years of experience in Analytical Chemist or related occupation
  • Experience with analytical method validations and stability studies

Work Rights

Not specified

Tailored Resume

Cover Letter