Associate Director, CMC Quality Assurance

Overview

Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazers in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs.

Responsibilities

• Provide technical leadership in support of activities governed by global GMP regulations
• Provide independent oversight and compliance direction for CMC Quality and product disposition, including CDMOs, CMOs, and Packaging Facilities
• Approve Protocols, Reports, Master Batch Records, and Executed Batch Records for Drug Product manufacturing
• Support development and implementation of Process Control Strategy
• Review and verify process data to assure compliance with data integrity and traceability requirements
• Disposition batches for human use in Clinical Trials ...