Project Manager II, Pharmaceutical Manufacturing

Project Manager II will oversee pharmaceutical manufacturing projects including aseptic processing and filling operations at the Irvine site. The role involves cross-functional coordination with customers and internal teams throughout the project lifecycle, from initial design through commercialization.

Responsibilities

• Assemble project teams, develop plans, timelines, and manage budgets for drug product manufacturing projects
• Conduct routine meetings with external customers and internal stakeholders to ensure deliverables are met
• Direct cross-functional teams including engineering, quality assurance, manufacturing, and maintenance
• Manage entire project lifecycle from initiation through planning, execution, monitoring, and closure
• Establish communication plans and oversee customer relations and resource allocation

Requirements

• 5+ years GMP manufacturing or product development experience
• Bachelor's degree in science, engineering, or related field
• Aseptic manufacturing experience required
• Strong knowledge of GMP, CFR, ICH, and ISO regulations
• Proficiency with Microsoft Office, Project, and SharePoint
• PMP certification preferred

Compensation: $125,000-$135,000 base