Biologics External Manufacturing Tech Transfer Lead

Merck; Charleston (WV); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. The role interfaces with External Partners to lead technical transfers and commercial supply for biologics vaccines and related products.

The candidate will manage complex, cross-functional teams, ensuring on-time delivery, risk mitigation, and site readiness for new and in-line products. The position emphasizes leadership in a matrix environment, lean manufacturing, and strong collaboration

Qualifications

• Bachelor’s degree in Engineering or applicable Science required.
• Minimum of 8 years post-bachelor’s degree experience in Drug Substance/Drug Product vaccines and/or biologics manufacturing, engineering, or technical support of operations.

Responsibilities

• Provide a single point of technical contact to External Partners and assigned sites.
• Provide technical oversight and planning for complex partnership models.
• Lead tech transfer delivery on time and within budget with partner sites.
• Guide External Partners on process configurations and validate adherence to standards.
• Collaborate with Procurement, External Manufacturing Ops, QA, Regulatory for partner evaluations.
• Ensure transfers and site readiness for new products and transfers.
• Identify partner risks and develop mitigations plans.
• Develop and execute validation strategies for new/existing products.
• Support partner manufacturing to resolve issues and optimize processes.
• Communicate across functions and coach change leadership.

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 or applicable Science

Advanced degree in Engineering, Science, or Business preferred

Job description

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. The role interfaces with External Partners to lead technical transfers and commercial supply for biologics vaccines and related products.

The candidate will manage complex, cross-functional teams, ensuring on-time delivery, risk mitigation, and site readiness for new and in-line products. The position emphasizes leadership in a matrix environment, lean manufacturing, and strong collaboration