Scientist II, Pharmaceutical Development Job at Neurocrine Biosciences, San Diego, CA

  • Neurocrine Biosciences
  • San Diego, CA

Job Description

Responsibilities

  • Design and develop phase-appropriate analytical methods supporting early pharmaceutical development activities
  • Execute developability assessment studies including solubility, stability, excipient compatibility, and form selection
  • Identify and communicate emerging pharmaceutical development data and risks to broader R&D team
  • Review and author technical documentation including regulatory submissions and scientific reports
  • Research and implement new instrumentation and analytical technologies to support development programs

Requirements

  • BS in Chemistry, Biochemistry, Chemical Engineering, or related field with 4+ years pharma industry experience in chemistry/analytical laboratory
  • MS in Chemistry, Biochemistry, Chemical Engineering, or related field with 2+ years similar experience; or PhD with relevant postdoc experience
  • Technical expertise in analytical method development and preformulation sciences
  • Proficiency with LC-MS and HPLC (SEC, UV, MS, IEX); working knowledge of DSC, TGA, PXRD, NMR, and particle-size analysis
  • Strong knowledge of regulatory guidelines for INDs, CTAs, NDAs, and BLAs preparation and authoring
  • Familiarity with multiple pharmaceutical dosage forms and fit-for-purpose method qualification/validation
  • Ability to work independently and collaboratively in fast-paced, matrixed team environment

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