Senior Director, Commercial Drug Product Manufacturing Operations - REVOLUTION Medicines

The Opportunity:

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.

Responsibilities:

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

• Lead implementation of post-approval manufacturing and packaging changes.

• Lead execution of continued process verification (CPV) activities across commercial manufacturing operations.

• Manage monitoring and trending of critical process parameters, process performance attributes, and product quality data.

• Support qualification and onboarding of manufacturing and primary packaging sites.

• Support commercial readiness activities including technology transfer, validation, and PPQ.

• Provide leadership for investigations, troubleshooting, and deviation management activities.

• Drive operational excellence initiatives focused on manufacturing performance and supply reliability.

• Partner cross-functionally with Pharmaceutical Development, MSAT, Quality, Regulatory Affairs, and Supply Chain organizations.

• Support commercialization and lifecycle management activities for marketed products.

Required Skills, Experience and Education:

• BS/MS/PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related scientific/engineering discipline.

• 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.

• Demonstrated strong operational and cross-functional team leadership, as well as people management skills.

• 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.

Preferred Skills:

• BS or MS degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related engineering/scientific discipline; advanced degrees are valued but not required.

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

• Direct experience managing commercial supply, manufacturing performance, and lifecycle management for one or more commercial pharmaceutical products.

• Proven track record of owning commercial manufacturing execution, including routine production, supply reliability, process monitoring, deviation management, and post-approval changes.

• Experience leading external manufacturing networks and CMO relationships for commercial products from launch through lifecycle management.

• Hands-on operational leadership experience within commercial manufacturing, technical operations, plant operations, or commercial MSAT organizations.

• Experience making risk-based operational decisions impacting commercial product supply, compliance, and business performance.

• Demonstrated success driving manufacturing performance improvements, capacity optimization, and operational excellence initiatives in a commercial environment. 

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