Associate Director, External Development and Manufacturing, Drug Product

MSD•Rahway, NJ

22h•Hybrid

About The Position

The 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. Its External Development and Manufacturing team executes drug product and device sourcing strategies across small- and large-molecule research and development. The Associate Director independently leads formulation, device, process development, and current Good Manufacturing Practice (GMP) drug product manufacturing activities at external providers. Working in matrix teams with 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.

Requirements

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.
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.
Required skills include business process design, business process implementation, business process improvements, clinical manufacturing, clinical supplies management, clinical trial management, data analysis, GMP, pharmaceutical manufacturing, pharmaceutical sciences, regulatory compliance, risk management, root cause analysis (RCA), solid dosage forms, and vendor management.

Nice To Haves

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.

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, managing 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.