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Associate Director, Analytical Development (Small Molecule)

$161.1k - $220k

Neurocrine Biosciences

Neurocrine Biosciences seeks an Associate Director of Analytical Development for small molecule pharmaceuticals to lead analytical teams and provide technical guidance on method development, validation, and regulatory submissions across early to commercial-stage programs.

Responsibilities

  • Lead analytical development activities including method development, validation, transfer, and stability studies for multiple programs
  • Provide technical expertise on complex analytical challenges and translate departmental strategy into operational plans
  • Oversee internal analytical work and external CRO/CMO partnerships to support program timelines
  • Contribute technical guidance to CMC regulatory submissions and analytical sections of regulatory dossiers
  • Coach and develop scientific staff while fostering a collaborative, high-performing team environment

Requirements

  • Bachelor's in Chemistry, Pharmacy, or related field plus 10+ years pharmaceutical industry experience
  • Master's degree in Chemistry, Pharmacy, or related field plus 8+ years pharmaceutical industry experience
  • PhD in Chemistry, Pharmacy, or related field plus 6+ years pharmaceutical industry experience
  • Expertise in analytical method development, validation, qualification, and troubleshooting
  • Knowledge of ICH and FDA guidance for analytical methods, stability, and CMC regulatory submissions
  • Previous people leadership experience managing scientific teams or external partners
  • Familiarity with cGMP requirements and CMC regulatory expectations for drug development
Vacancy posted 16 days ago
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