Senior Manufacturing Operations Leader — GMP Startup

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

Benefits offered by this job

Annual incentive bonus

Equity opportunity

Comprehensive benefits package

Paid time off

Job summary

Alnylam Pharmaceuticals seeks a Senior Manager, Manufacturing Operations to drive the start‑up of a new Drug Substance manufacturing train in Norton, MA. You will lead multi-shift teams, oversee equipment commissioning and qualification, and implement enterprise systems for a seamless transfer to commercial production.

The role requires extensive GMP manufacturing experience, strong leadership, and cross‑functional collaboration to ensure schedule adherence, quality, and regulatory readiness in

Qualifications

• BS in scientific or engineering field preferred.
• 10+ years of GMP manufacturing experience with 4+ years in a supervisory role.
• Deep knowledge of US and international GMP regulations and inspections.
• Ability to work independently in a fast-paced start-up environment.
• Strong collaboration, communication, and organizational skills.

Responsibilities

• Plans, schedules, and manages deliverables for Train 2 readiness and PPQ execution.
• Lead SAP design, implementation, and scheduling to begin production activities.
• Oversee commissioning/qualification testing of new equipment and on-the-floor support.
• Hire and train multiple shifts and transition to daily production activities.
• Drive GMP compliance and partner with QA/QC for timely document reviews.

Skills

Leadership

GMP knowledge

Cross-functional collaboration

Project management

SAP

MS Office

Process automation

Education

BS in scientific or engineering field

Tools

SAP

MS Office

PI Historian

LIMS

MES/eBR

Job description

Alnylam Pharmaceuticals seeks a Senior Manager, Manufacturing Operations to drive the start‑up of a new Drug Substance manufacturing train in Norton, MA. You will lead multi-shift teams, oversee equipment commissioning and qualification, and implement enterprise systems for a seamless transfer to commercial production.

The role requires extensive GMP manufacturing experience, strong leadership, and cross‑functional collaboration to ensure schedule adherence, quality, and regulatory readiness in