Key Responsibilities

• Drive formulation & process development activities for late-stage clinical & commercial programs.
• Lead scale-up, tech transfer, & validation to commercial manufacturing sites (internal & external).
• Manage manufacturing activities including monitoring production campaigns, reviewing of batch records, & process batch data.
• Support resolution of quality investigations or events.
• Author & review CMC sections for regulatory submissions.
• Present technical data & strategic decisions to cross functional teams & senior management.