Associate Director, Biologics External Manufacturing Tech

Merck; Denver (CO); Remote; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. The role leads technical transfers with External Partners, ensuring on-time, compliant commercial supply across biologics modalities.

The candidate will manage cross-functional teams, guide risk mitigation, and drive process optimization across the external manufacturing network in the US, with location flexibility and strong leadership required.

Qualifications

• Bachelor’s degree in Engineering or applicable Science required.
• Eight years post-bachelor’s degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations required.

Responsibilities

• Provide technical leadership for tech transfer and external partner collaborations.
• Lead cross-functional teams across multiple sites to ensure on-time, within-budget tech transfer.
• Assess external partner capabilities and validate proposed processes against standards.
• Develop and implement validation strategies for new and existing products.
• Support risk management and change control for external manufacturing programs.

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/Science

Advanced degree in Engineering/Science/Business

Job description

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. The role leads technical transfers with External Partners, ensuring on-time, compliant commercial supply across biologics modalities.

The candidate will manage cross-functional teams, guide risk mitigation, and drive process optimization across the external manufacturing network in the US, with location flexibility and strong leadership required.