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Associate Principal Scientist, Long-Acting Injectable Sterile Product Development

Merck
September 04, 2026
Full-time
Remote friendly (Rahway, NJ)
Worldwide
Clinical Research and Development
Role: Associate Principal Scientist leading long‑acting injectable (LAI) formulation development within sterile product development, focusing on depot, sustained‑release, and controlled‑delivery systems. Responsibilities: serve as scientific leader across multidisciplinary teams for LAI design and lifecycle management, optimize release mechanisms and excipient systems, interpret studies on release kinetics and stability, support process scale‑up and technology transfer, and contribute to regulatory submissions. Collaborate closely with Clinical, Quality, Regulatory, and Manufacturing functions to define quality attributes, support clinical strategies, and ensure regulatory compliance. Mentor junior scientists and stay abreast of emerging LAI technologies to foster innovation. Requirements: Ph.D. with 4+ years or Master’s with 8+ years or Bachelor’s with 10+ years in Pharmaceutics, Pharmaceutical Sciences, or related disciplines; deep expertise in parenteral drug products, controlled‑release mechanisms, drug–polymer interactions, and formulation stability; experience applying QbD and DOE principles; knowledge of regulatory expectations for sterile injectables; demonstrated leadership in cross‑functional teams. Preferred: experience with polymer depots, microspheres, nanosuspensions, or device–drug integration; supporting global regulatory filings; and contributions to scientific publications or patents. High‑Value: expertise in long‑acting injectables, drug delivery systems, formulation science, and CMC regulatory processes. Work setup: 10% travel, based in a research or development setting.