Biologics MES Program & Portfolio Lead

Lancesoft; Lexington (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

Lancesoft seeks a Senior MES Program/Portfolio Manager to oversee multiple MES projects in a GMP setting. You will track milestones, Change Controls, and CAPAs, coordinating with ERP, automation, and lab systems.

The role requires hands-on experience with MES (Client-X preferred) and strong ISA-95/ISA-88 knowledge. Ideal candidates have 5+ years in digital project management in GMP and can lead cross-functional teams in a matrixed environment, working with vendors and internal partners to drive

Qualifications

• 3+ years of MES experience with relevant interfaces (ERP, Automation, Lab Systems).
• 5+ years in digital project/program management within GMP environments.
• Familiarity with ISA-95/ISA-88 models and client MES systems is preferred.
• Ability to lead meetings, identify risks and navigate a complex matrix structure.

Responsibilities

• Act as Portfolio/Program manager for multiple MES projects at MA Bio Ops.
• Track milestones, Change Controls and CAPAs across projects.
• Lead meetings, manage cross-project dependencies and risks.
• Coordinate with external vendors and internal stakeholders.

Skills

Project management

Agile methodologies

Waterfall

Risk management

Vendor management

Cross-functional leadership

Tools

TrackWise

Veeva systems

Confluence

JIRA

ERP interfaces

Automation GMP knowledge

Job description

Lancesoft seeks a Senior MES Program/Portfolio Manager to oversee multiple MES projects in a GMP setting. You will track milestones, Change Controls, and CAPAs, coordinating with ERP, automation, and lab systems.

The role requires hands-on experience with MES (Client-X preferred) and strong ISA-95/ISA-88 knowledge. Ideal candidates have 5+ years in digital project management in GMP and can lead cross-functional teams in a matrixed environment, working with vendors and internal partners to drive