Director, CMC Quality

Company Name

Aligos Therapeutics

Job Description

The Director, CMC Quality at Aligos Therapeutics provides quality oversight and support for cGMP-related CMC activities. Responsibilities include developing strategies for compliant manufacturing of clinical supplies and commercial products, guiding product progression, overseeing internal and vendor GMP activities, and managing CMC quality risks.

Key Duties

• Reviewing batch records and analytical testing
• Assessing deviations
• Ensuring adherence to GxP requirements

Requirements

• BS/MS degree
• 10+ years of biopharmaceutical quality management experience
• Experience with small molecule CMC oversight
• Strong knowledge of GxP principles