Global Drug Substance CapEx Program Leader

Fraser Dove International; New Jersey; On-site; USD 150,000 - 230,000; Full time

Job summary

Fraser Dove International seeks a Global Project Manager to lead a major portfolio of capital projects across its US Drug Substance manufacturing network, with initial focus on the East Coast.

You will oversee greenfield and brownfield CapEx across US sites, managing $10M-$15M+ packages within a broader program over $100M, coordinating with Quality, Regulatory, Operations and Commercial teams through CQV and technology transfer activities.

Qualifications

• 10+ years of pharma/biotech/CDMO capital project leadership.
• Experience delivering projects in Drug Substance or API manufacturing.
• Strong understanding of US construction, engineering contractors and cGMP environments.
• Experience leading complex programs across multiple sites and influencing senior stakeholders.
• Engineering background in chemical, mechanical or bioengineering.

Responsibilities

• Lead a portfolio of greenfield and brownfield CapEx projects across US Drug Substance manufacturing sites.
• Manage multiple $10M-$15M+ project packages as part of a broader investment programme exceeding $100M.
• Oversee project scope, budget, schedules, stage gates, change controls and external EPC/EPCM partners.
• Lead and influence Project Managers, site engineering teams, contractors and vendors across multiple locations.
• Support CQV and technology transfer activities through commissioning, qualification and validation.

Skills

Capital project leadership

Cross-site program management

Stakeholder influence

cGMP knowledge

Education

Engineering background (Chemical/Mechanical/Bioengineering)

Job description

Fraser Dove International seeks a Global Project Manager to lead a major portfolio of capital projects across its US Drug Substance manufacturing network, with initial focus on the East Coast.

You will oversee greenfield and brownfield CapEx across US sites, managing $10M-$15M+ packages within a broader program over $100M, coordinating with Quality, Regulatory, Operations and Commercial teams through CQV and technology transfer activities.