Senior Scientist, CMC Analytical

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