Principal Scientist, CMC Analytical

Job Summary

To support the advancement of innovative veterinary therapies, the remote Principal Scientist, CMC Analytical will manage analytical development and quality control strategies for oral solid dosage products, ensuring compliance with regulatory standards through advanced technical analysis and method validation.

Key responsibilities

• Lead the analytical development and quality control strategy, setting technical direction for method development and validation
• Serve as the primary technical point of contact with CDMO and contract laboratory partners, resolving complex analytical issues
• Prepare and author CMC analytical sections of regulatory documents, ensuring data packages are scientifically sound and submission-ready

Required qualifications

• Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, or a related field
• 10+ years of experience in QC laboratory operations and/or analytical method development, preferably in small-molecule oral solid dosage products
• Extensive knowledge of analytical chemistry principles related to drug substance and product development
• Experience managing CDMO relationships and understanding cGMP, ICH/VICH, FDA, and EMA expectations
• Proven track record in QC data interpretation and support of regulatory filings