Global GMP Clinical Manufacturing Leader

GSK

Marietta (PA)

On-site

USD 250,000 - 350,000

Full time

35 hours ago
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Job summary

GSK is seeking a VP, Global GMP Clinical Manufacturing Operations to lead the Medicines Global Clinical Manufacturing Operations function. You will ensure timely scale-up, manufacture, and GMP-compliant drug substances and products for clinical trials, and partner with internal and external teams to meet R&D milestones.

The role requires guiding a multi-site operation across six locations, driving modernization, and delivering high-quality clinical supplies, while maintaining compliance with

Qualifications

  • Master’s degree in Chemical Engineering, Process Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or related field.
  • 10+ years experience leading GMP manufacturing operations in a large pharma/biotech setting.
  • Experience in cross-modality drug development/manufacturing across all CMC activities.
  • Experience with highly regulated GMP processes for medicines/vaccines.

Responsibilities

  • Line leadership of global department of ca 300 scientists, engineers, and technicians across 6 sites.
  • Ensure on-time scale-up, manufacture and supply to R&D GSK-sponsored clinical trials.
  • Drive modernization and digitalisation as part of CMC Digital Strategy & Acceleration goals.
  • Oversee major capital projects including Marietta Steriles Facility and UM Flex Factory.
  • Monitor external CMO landscape to strengthen internal manufacturing competitiveness.
  • Develop and implement strategic workforce plans and succession pipelines.

Skills

GMP Manufacturing
Strategic Leadership
Regulatory Compliance
Budget Oversight
Drug Substance/Drug Product

Education

Master’s in Chemical Engineering
PhD preferred

Job description

GSK is seeking a VP, Global GMP Clinical Manufacturing Operations to lead the Medicines Global Clinical Manufacturing Operations function. You will ensure timely scale-up, manufacture, and GMP-compliant drug substances and products for clinical trials, and partner with internal and external teams to meet R&D milestones.

The role requires guiding a multi-site operation across six locations, driving modernization, and delivering high-quality clinical supplies, while maintaining compliance with

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