Senior MES Program/Portfolio Manager

Lancesoft; Lexington (MA); Presencial; USD 140.000 - 200.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Project management

Agile methodologies

Waterfall

Risk management

Vendor management

Cross-functional leadership

Herramientas

TrackWise

Veeva systems

Confluence

JIRA

ERP interfaces

Automation GMP knowledge

Descripción del empleo

- Job Title:

Senior MES Program/Portfolio Manager

- Job Description:

Candidate will act as the Portfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at MA Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs. Required: 3+ years experience with MES systems (Client-X preferred) as well as relevant interfaces (ERP, Automation, Lab Systems). Direct experience with Biologics manufacturing processes and equipment. Understand the ISA-95 and ISA-88 models. 5+ years experience in digital project and program management in a GMP environment. Experienced with common project management methodologies including Agile and Waterfall. Expected to be able to work independently, take initiative, and navigate complex matrixed environment to influence individuals and teams across the organization. Comfortable working with external vendors, where applicable. Able to lead meetings, identify projects risks, and understand cross project dependencies. Preferred: Experience with Client-X MES system. Experience with Trackwise, Veeva systems (or similar) Experience with Atlassian s Confluence and JIRA software. Knowledge of Automation Systems in GMP manufacturing operations.