Senior Director, Commercial Drug Product Manufacturing Operations

15+ years of experience in pharmaceutical or biotechnology manufacturing, technical operations, or commercial operations with a strong track record of technical expertise and leadership.

Strong experience supporting commercial drug product manufacturing and primary packaging operations.

Experience managing CMOs and external manufacturing partners.

Experience supporting manufacturing process validation, packaging validation, PPQ execution, and validation lifecycle activities.

Experience supporting continued process verification (CPV) and commercial process monitoring programs.

Demonstrated leadership responsibility for commercial drug product manufacturing operations supporting approved and marketed products.

The Senior Director, Commercial Drug Product Manufacturing Operations will lead commercial drug product manufacturing and primary packaging activities within the Drug Product Development & Manufacturing organization.

The role will oversee execution of commercial manufacturing operations across external manufacturing and packaging partners to support reliable commercial supply and lifecycle management.

Responsibilities include commercial readiness activities, site qualification, technology transfer, process validation, PPQ execution, post-approval changes, troubleshooting, continued process verification (CPV), and operational excellence initiatives.

The role will also support execution of commercial process monitoring activities to ensure sustained process performance and product quality.

Lead execution of commercial manufacturing and primary packaging operations across CMOs and packaging partners.

Lead implementation of post-approval manufacturing and packaging changes.