External Development & Manufacturing Lead (Hybrid)

Merck & Co.; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus and long-term incentive

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Rahway, NJ is seeking an Associate Director to lead formulation, device, process development, and external drug product manufacturing activities at contract providers.

You will work in matrix teams across Product Development, Quality, Analytical, Procurement, and Global Clinical Supply to advance oral solid dosage forms, biologics, vaccines, and device combinations. The role emphasizes vendor management, project leadership, and regulatory compliance within GMP frameworks, with

Qualifications

• Relevant pharmaceutical development and external manufacturing experience.
• Vendor and project management with cross-functional delivery.
• GMP knowledge and regulatory compliance in drug product development.

Responsibilities

• Plan and coordinate formulation, device, process development, and clinical manufacturing at CROs/CMOs.
• Provide manufacturing and compliance expertise to project teams; manage timelines and risks.
• Develop proposals and evaluate vendors for fit, capacity, and geography.
• Maintain vendor relationships aligned with pipeline needs across products.
• Support technology evaluations and ensure appropriate scope and agreements.
• Collaborate to optimize externalization and portfolio-level excellence.
• Provide business/logistical support for non-manufacturing activities including device development.
• Travel approximately 10%.

Skills

GMP knowledge

Regulatory compliance

Vendor management

Cross-functional collaboration

Project management

Excellent communication

Strategic thinking

Root Cause Analysis (RCA)

Clinical manufacturing

Data analysis

Education

B.S. with 8 years experience

M.S. with 6 years

Ph.D. with 4 years

Tools

SAP

Job description

Merck & Co. in Rahway, NJ is seeking an Associate Director to lead formulation, device, process development, and external drug product manufacturing activities at contract providers.

You will work in matrix teams across Product Development, Quality, Analytical, Procurement, and Global Clinical Supply to advance oral solid dosage forms, biologics, vaccines, and device combinations. The role emphasizes vendor management, project leadership, and regulatory compliance within GMP frameworks, with