Global GMP Clinical Manufacturing Leader

GlaxoSmithKline

Upper Providence (Delaware County)

On-site

USD 250,000 - 450,000

Full time

5 days ago
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Job summary

GlaxoSmithKline seeks a senior leader for Global GMP Clinical Manufacturing Operations to direct six manufacturing locations across multiple countries, ensuring on-time scale-up, GMP-compliant drug substance and product for clinical trials. The role emphasizes patient safety, data integrity, and delivering R&D objectives through strategic modernization and external partnerships.

You will report to the SVP of CMSC, collaborating with DDS, GSC, Finance, Quality, Regulatory, and Technical functions

Qualifications

  • Advanced leadership of large scientific/technical teams
  • Experience in GMP manufacturing operations
  • Experience across multi-modality drug development/manufacturing
  • Experience with regulated GMP processes for medicines/vaccines
  • Budget responsibility in hundreds of millions
  • Capital investment project oversight over 100M

Responsibilities

  • Line leadership of global department of ca 300 scientists, engineering, process technicians and manufacturing experts across 6 sites
  • Lead global medicines GMP Operations to ensure timely scale-up, manufacture and supply for clinical trials
  • Implement modernisation and digitalisation across GMP Manufacturing Operations
  • Drive CMC Digital Strategy and Acceleration goals
  • Oversight of design/build of new GMP pilot plants and major capital projects
  • Monitor external CMO landscape to strengthen internal capabilities
  • Deliver technical investment proposals to governance boards
  • Develop workforce plan and succession with external collaborations
  • Measure performance with a metrics-driven system
  • Lead major change programs with robust engagement and communication plans

Skills

Leadership
GMP Manufacturing
Cross-functional
Digital Strategy
Capital Projects
People Leadership

Education

PhD in Engineering or related
Master's degree in relevant field

Tools

Project Management
Regulatory Systems

Job description

GlaxoSmithKline seeks a senior leader for Global GMP Clinical Manufacturing Operations to direct six manufacturing locations across multiple countries, ensuring on-time scale-up, GMP-compliant drug substance and product for clinical trials. The role emphasizes patient safety, data integrity, and delivering R&D objectives through strategic modernization and external partnerships.

You will report to the SVP of CMSC, collaborating with DDS, GSC, Finance, Quality, Regulatory, and Technical functions

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