Phaidon International - Vernon, CA
posted about 1 month ago
Full-time - Principal
Vernon, CA
Professional, Scientific, and Technical Services
About the position
The Principal Scientist in Analytical Development will lead and oversee analytical initiatives for small molecules, ensuring compliance with regulatory standards while collaborating with various teams to support late-stage development programs and regulatory filings. This role emphasizes technical expertise, mentorship, and adherence to GLP and GMP practices throughout the analytical development lifecycle.
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.
Requirements
- 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.
