Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)
Merck · Rahway, New Jersey, United States
About this role
<p style="text-align:left"><b>Job Description</b></p><p style="text-align:inherit"></p><p><span><b>Job Description</b></span></p><p><span>Are you enthusiastic and driven to create and lead execution of combination product testing strategies for innovative combination products?</span></p><p><span> </span></p><p><span>Join our company’s Device Development & Technology (DD&T) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DD&T Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.</span></p><p><span> </span></p><p><span>The Associate Principal Scientist will provide end‑to‑end technical and project leadership for the definition, integration, and execution of comprehensive testing strategies in support of the overall control strategy for drug–device combination products. This role has a primary focus on design verification while encompassing the full spectrum of testing activities, including test method development and validation, analytical transfers, incoming testing, in-process, release testing, and testing readiness to enable successful clinical introduction and commercialization.</span></p><p><span> </span></p><p><span>This position plays a critical leadership role across the product lifecycle, partnering with cross‑functional teams and suppliers to ensure testing strategies are aligned with development, manufacturing, regulatory, and quality objectives
In addition to design verification, the Associate Principal Scientist will contribute to and support key validation activities such as drug product manufacturing processes and combination product final assembly process validations, ensuring robust and compliant execution from development through commercial
Apply for this role on Merck’s official careers site.