Principal Scientist, QC Analytical

Job Summary

Leading method transfer, validation, and routine testing, the full-time Principal Scientist, QC Analytical in Cell Therapy will serve as a subject matter expert in bioanalytical techniques while managing complex projects and representing the department in regulatory inspections.

Key responsibilities

• Lead method transfer/validation and routine testing of in-process, final product, and stability samples using bioanalytical techniques
• Develop and execute methods, protocols, and reports in compliance with regulatory and corporate guidelines
• Represent the department in product review boards and regulatory inspections, authoring responses to regulatory requests

Required qualifications

• Bachelor's degree in a scientific field required; advanced degree preferred, with a PhD in bioanalytical science being ideal
• 10+ years of relevant analytical testing experience, including 2+ years in Quality Control
• Expertise in bioanalytical techniques such as cell-based assays, ELISA, qPCR, and flow cytometry
• Advanced technical writing skills and strategic thinking abilities
• Proven ability to work independently and collaboratively in a fast-paced environment