Associate Director, External Drug Product & Device Dev

Merck; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Merck in New Jersey is seeking an Associate Director to lead formulation, device, process development, and external drug product manufacturing at contract providers.

You will coordinate with product development, Quality, Analytical, Procurement, and Global Clinical Supply teams to advance oral solid dosage forms, biologics, vaccines, and device combinations while ensuring GMP compliance and project delivery.

Qualifications

• Experience with external manufacturing and contract organizations.
• Demonstrated vendor and project management, cross-functional collaboration, and independent execution of business deliverables.
• Strong knowledge of GMP, regulatory expectations, manufacturing compliance, and drug product development.

Responsibilities

• Plan and coordinate formulation, device, process development, and clinical manufacturing activities at contract research and manufacturing organizations.
• Provide manufacturing, compliance, and execution expertise to project teams; manage timelines, deliverables, risks, and issue resolution.
• Develop project requests for proposals; evaluate responses and recommend vendors based on technical fit, unit operations, safety classification, capacity, timing, geography, and clinical supply needs.
• Identify, establish, and maintain trusted vendor relationships aligned with pipeline needs across oral formulation, sterile and specialty products, device development, and discovery pharmaceutical sciences.
• Support technology evaluations through external partner discussions, confidentiality agreements, technical information exchange, and guidance on appropriate scope and agreement structure.
• Collaborate across scientific and operational functions to optimize externalization activities, improve workflows, and advance portfolio-level operational excellence.
• Provide business and logistical support for non-manufacturing activities, including device development, device evaluation, and process development.
• 10% Travel

Skills

Vendor Management

Cross-functional Collaboration

Regulatory Compliance

GMP Knowledge

Drug Product Development

Project Management

Strategic Thinking

Education

PhD in Chemical Engineering/Pharmaceutical Sciences

MS in Chemical Engineering/Pharmaceutical Sciences

BS in Chemical Engineering/Pharmaceutical Sciences

Tools

SAP

Job description

Merck in New Jersey is seeking an Associate Director to lead formulation, device, process development, and external drug product manufacturing at contract providers.

You will coordinate with product development, Quality, Analytical, Procurement, and Global Clinical Supply teams to advance oral solid dosage forms, biologics, vaccines, and device combinations while ensuring GMP compliance and project delivery.