Senior GMP Manufacturing Start-up Lead

Alnylam Pharmaceuticals; Norton (MA); On-site; USD 135,000 - 182,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Senior Manager, Manufacturing Operations to drive the Norton, MA commercial Drug Substance train startup. You will oversee equipment commissioning, qualification, tech transfer, SAP roll-out, and MES/LIMS integration while building and managing multiple shifts for GMP production.

You will coordinate with Quality, Engineering, and Compliance to ensure timely PPQ batches and a robust operational readiness program as the site scales to full commercial production.

Qualifications

• BS in scientific or engineering field required.
• 10+ years in GMP manufacturing with 4+ years of supervisory experience.
• Experience with start-up, commissioning/qualification of new equipment, and tech transfer.

Responsibilities

• Plan and manage train readiness and PPQ execution.
• Lead SAP config, cross-functional collaboration, and schedule development.
• Oversee commissioning/qualification testing and on-floor support.
• Hire and train shifts; transition to daily production activities.
• Drive KPI to maximize schedule adherence and process efficiency.
• Provide coaching and development plans to reports.
• Support audits and CAPA processes with Quality functions.

Skills

GMP compliance

leadership

cross-functional collaboration

project management

communication

Education

B.S. in science or engineering

Tools

SAP

MES/eBR

PI Historian

LIMS

Job description

Alnylam Pharmaceuticals seeks a Senior Manager, Manufacturing Operations to drive the Norton, MA commercial Drug Substance train startup. You will oversee equipment commissioning, qualification, tech transfer, SAP roll-out, and MES/LIMS integration while building and managing multiple shifts for GMP production.

You will coordinate with Quality, Engineering, and Compliance to ensure timely PPQ batches and a robust operational readiness program as the site scales to full commercial production.