Biologics External Manufacturing Engineering Lead

Merck; Saint Paul (MN); Remote; USD 142,000 - 224,000; Full time

Job summary

Merck in the United States is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology to lead technical transfers with External Partners and ensure on-time, within-budget delivery of biologics manufacturing initiatives.

The role requires collaboration with Operations, Quality, Regulatory and Procurement to drive risk management, site readiness, and continuous improvement across the External Partner network.

Qualifications

• Expertise and demonstrated accomplishments leading technical transfers.
• Experience leading cross-functional teams in manufacturing operations.
• Lean Manufacturing expertise with productivity improvements.

Responsibilities

• Provide technical leadership for tech transfer delivery to External Partners.
• Coordinate cross-functional teams to ensure on-time, within-budget transfers.
• Develop validation strategies for new and existing products.
• Support process changes and site readiness with External Partners.
• Assess partner risk and implement mitigation plans.

Skills

Adaptability

Automation Systems

Capital Project Management

Change Management

Clinical Manufacturing

Data Analysis

Decision Making

Drug Product Manufacturing

Interpersonal Relationships

Lean Manufacturing

Manufacturing Scale-Up

Regulatory Compliance

Root Cause Analysis

Strategic Thinking

Technical Transfer

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Merck in the United States is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology to lead technical transfers with External Partners and ensure on-time, within-budget delivery of biologics manufacturing initiatives.

The role requires collaboration with Operations, Quality, Regulatory and Procurement to drive risk management, site readiness, and continuous improvement across the External Partner network.