Principal Scientist Analytical Development

3 weeks ago


San Francisco, United States EPM Scientific - Phaidon International Full time

Principal Scientist, Analytical Development

Location: San Francisco, California

Key Responsibilities:

  • Spearhead and supervise analytical development initiatives for small molecules, including method development, validation, and testing in support of OSD.
  • Collaborate closely with interdisciplinary teams including R&D, Formulation Development, Regulatory Affairs, and Quality Assurance to bolster late-stage development programs and facilitate regulatory filings.
  • Ensure steadfast adherence to regulatory guidelines, GLP, and GMP practices throughout the analytical development lifecycle.
  • Offer technical proficiency and guidance on analytical challenges, troubleshooting, and resolution.
  • Cultivate and mentor junior scientists within the Analytical Development team, nurturing a culture of ongoing learning and growth.

Qualifications:

  • Hold a Ph.D. in Analytical Development or a related discipline.
  • Accumulate a minimum of 3-5 years of industry experience in analytical development, with a focus on small molecules.
  • Demonstrate proficiency with solid-state characterization techniques like X-ray diffraction (XRD), differential scanning calorimetry (DSC), and microscopy.
  • Exhibit a track record of successfully supporting late-stage development programs and regulatory filings (NDA).
  • Possess a comprehensive understanding of GLP and GMP regulations and guidelines.
  • Showcase exceptional communication, leadership, and project management capabilities.
  • Thrive in a dynamic, fast-paced environment and adeptly manage multiple priorities.

If you're looking to join a top Biopharmaceutical Company, apply directly or email your resume

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