Principal Scientist, Analytical Development
Location: 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.
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