Associate Director, External Development and Manufacturing, Drug Product

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

Our company's Pharmaceutical Sciences and Device Development organization translates molecules into medicines from discovery through registration by designing, developing, scaling, and transferring formulations, devices, and manufacturing processes. The External Development and Manufacturing team executes the drug product and device sourcing strategy across small- and large-molecule research and development.

The Associate Director independently leads formulation, device, process development, and current Good Manufacturing Practice drug product manufacturing activities at external providers. Working within matrix teams that include product development, Quality, Analytical, Procurement, and Global Clinical Supply, the role supports oral solid dosage forms, biologics, vaccines, specialty products, and drug-device combinations. The position also contributes to operational excellence, external network strategy, and productive vendor relationships.

Key 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

Education Minimum Requirement

• B.S. with at least 8 years of relevant industrial experience, or
• M.S. with at least 6 years, or
• Ph.D. with at least 4 years in Chemical Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline.

Required Experience and Skills

• Relevant pharmaceutical development, clinical manufacturing, supply chain, or external manufacturing experience.
• 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.
• Excellent communication, facilitation, and stakeholder engagement skills with the ability to influence teams without direct authority.
• Strategic thinking, business acumen, creativity, sound judgment, and the ability to navigate ambiguity and solve complex problems with rigor.

Preferred Experience and Skills

• Direct drug product manufacturing, specialized scientific, or device development experience.
• Experience leading business process optimization, continuous improvement, or transformation initiatives.
• Familiarity with SAP for material build and transactions

Required Skills

• Business Process Design
• Business Process Implementation
• Business Process Improvements
• Clinical Manufacturing
• Clinical Supplies Management
• Clinical Trial Management
• Data Analysis
• Good Manufacturing Practices (GMP)
• Pharmaceutical Manufacturing
• Pharmaceutical Sciences
• Regulatory Compliance
• Risk Management
• Root Cause Analysis (RCA)
• Solid Dosage Forms
• Vendor Management

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

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