Senior Manager, QC Stability

Job Summary

A company is looking for a Senior Manager, QC Stability Management.

Key Responsibilities

• Develop and manage stability programs in compliance with regulatory guidelines
• Analyze stability data and publish reports to support product shelf life and storage conditions
• Manage QC-related change controls, deviations, and investigations

Required Qualifications

• MS or BS in Chemistry, Biochemistry, or related discipline with at least 6 years of experience in clinical-stage biopharma
• Proven technical track record in Quality Control with a focus on stability testing
• Experience in developing and managing stability programs and analytical methods
• Strong knowledge of cGMPs and international regulatory guidelines
• Experience working with CDMOs and CTLs