Sr. Scientist, CMC Analytical

Bachelor’s or Advanced degree (master’s or Ph.D.) in Analytical Chemistry, Chemistry, Biochemistry or a related field. 6+ years of experience in quality control laboratory, analytical or method development, with significant experience with small molecules preferred. Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in process control, and characterization. Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired. Deep understanding of cGMP, ICH/VICH, FDA, and EMA analytical expectations. Proven track record of QC data interpretation and support of regulatory filings. Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.).

Perform in-depth review and interpretation of analytical data (HPLC/UPLC, Dissolution, KF, GC, etc) across release and stability programs. Identify subtle trends, shifts, or outliers in complex data sets that may impact product quality, method robustness, or long-term stability. Provide expert technical input during OOS, OOT, and atypical result investigations, ensuring scientifically sound conclusions. Lead trending of release and stability data across programs, highlighting emerging quality signals and risks. Review and assess data from method development, transfer, qualification, and validation activities. Ensure Quality Control data packages are complete, scientifically defensible, and compliant with cGMP and regulatory expectations.