Senior Scientist, CMC Analytical

Job Summary

A company is looking for a Sr. Scientist, CMC Analytical.

Key Responsibilities

• Perform in-depth review and interpretation of analytical data across release and stability programs
• Identify trends, shifts, or outliers in complex data sets that may impact product quality
• Provide expert technical input during investigations of atypical results and ensure compliance with cGMP and regulatory expectations

Required Qualifications

• Bachelor's or advanced degree in Analytical Chemistry, Chemistry, Biochemistry, or a related field
• 6+ years of experience in quality control laboratory or analytical method development
• Deep knowledge of analytical chemistry for small molecule release and stability method development
• Prior experience managing CDMO relationships and Quality Control programs
• Understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations