Senior MES Program Lead – Biologics GMP Operations

The Fountain Group; Lexington (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

The Fountain Group is seeking a Portfolio/Program Manager to lead multiple MES projects at MA Bio Ops. You will track milestones, Change Controls, and CAPAs, and collaborate with cross-functional teams in a GMP setting.

Ideal candidates bring 5+ years in digital project management, 3+ years MES experience, ISA-95/ISA-88 knowledge, and proven vendor coordination skills in a matrixed organization.

Qualifications

• 5+ years in digital project and program management in a GMP environment.
• 3+ years MES systems experience and interfaces (ERP, Automation, Lab).
• Direct experience with Biologics manufacturing processes and equipment.
• ISA-95 and ISA-88 knowledge.
• Experienced with Agile and Waterfall methodologies.
• Ability to work independently in a matrixed environment and influence teams.
• Comfortable working with external vendors.
• Able to lead meetings, identify risks, and manage dependencies across projects.

Responsibilities

• Act as Portfolio/Program Manager for concurrent MES projects.
• Track milestones, Change Controls, and CAPAs.
• Coordinate across GMP manufacturing operations.
• Identify project risks and cross-project dependencies.
• Lead stakeholder meetings and vendor coordination.

Skills

Digital project management

Program management

GMP environment experience

Risk management

Vendor management

Meeting facilitation

Cross-functional collaboration

Independent work

Leadership

ISA-95/ISA-88 knowledge

Education

No degree specified

Tools

TrackWise

Veeva

Confluence

JIRA

Automation systems

Job description

The Fountain Group is seeking a Portfolio/Program Manager to lead multiple MES projects at MA Bio Ops. You will track milestones, Change Controls, and CAPAs, and collaborate with cross-functional teams in a GMP setting.

Ideal candidates bring 5+ years in digital project management, 3+ years MES experience, ISA-95/ISA-88 knowledge, and proven vendor coordination skills in a matrixed organization.