Senior Manager, Manufacturing Operations

Scorpion Therapeutics; Norton (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Norton, MA seeks a Senior Manager, Manufacturing Operations to lead the start-up and ongoing management of the new commercial Drug Substance manufacturing train, including equipment commissioning and tech transfer.

You will drive GMP manufacturing readiness, establish KPIs, and supervise cross-functional teams with Quality, Engineering and Supply Chain to meet regulatory expectations.

Qualifications

• BS in science or engineering required.
• 10+ years GMP pharma/biotech manufacturing experience.
• 4+ years supervision/leadership experience.
• Deep knowledge of cGMP, FDA, EMA standards.
• Hands-on plant startup and troubleshooting.

Responsibilities

• Oversee operational readiness.
• Lead SAP integration supporting GMP manufacturing.
• Manage equipment qualification.
• Plan facility layout.
• Develop electronic workflows.
• Hire/train staff.
• Establish KPIs.
• Ensure GMP compliance.
• Collaborate across Quality, Engineering, and Supply Chain.
• Support regulatory audits.

Skills

Leadership

GMP knowledge

Regulatory audits

Startup experience

Cross-functional leadership

Education

B.S. in science or engineering

Tools

SAP

MS Office

Process automation tools

MES/eBR systems

Job description

Role

Senior Manager, Manufacturing Operations responsible for start-up and management of Norton's new commercial Drug Substance manufacturing train, including equipment commissioning, tech transfer, enterprise system implementation, and production ramp-up.

Responsibilities

• oversee operational readiness
• lead SAP integration supporting GMP manufacturing
• manage equipment qualification
• plan facility layout
• develop electronic workflows
• hire/train staff
• establish KPIs
• ensure GMP compliance
• collaborate across functions (Quality, Engineering, Supply Chain)
• support regulatory audits

Requirements

• B.S. in science or engineering
• 10+ years in GMP pharmaceutical/biotech manufacturing
• 4+ years supervisory leadership
• deep knowledge of cGMP regulations, FDA, EMA standards
• hands‑on experience with plant startup and troubleshooting
• proficiency in SAP, MS Office, process automation tools
• experience with MES/eBR systems preferred

High-Value Qualifications

• biologics or small molecule Drug Substance manufacturing
• commercial stage
• GMP and regulatory audits
• cGMP compliance
• equipment commissioning
• cross‑functional leadership in a startup environment

Work Setup

on-site Norton, MA, with on-call support.