Principal Scientist, Long-Acting Injectable Sterile Product Development

Role: Principal Scientist leading long-acting injectable (LAI) formulation development, focusing on depot, sustained-release, and controlled-delivery parenteral systems from preclinical through commercialization. Responsibilities: provide scientific leadership on design, optimization, and lifecycle management of LAIs; develop release mechanisms and excipient strategies; guide cross-functional teams on formulation, drug properties, process development, and regulatory submissions; support process scale-up and technology transfer; mentor junior scientists; stay abreast of emerging LAI technologies. Requirements: Ph.D. with 7+ years or MS with 10+ years or BS with 14+ years in Pharmaceutics, Chemical Engineering, or related field; extensive experience in parenteral drug product development, especially long-acting injectables; expertise in controlled-release mechanisms, drug–polymer/excipient interactions, stability, and performance characterization; knowledge of CMC regulatory requirements for sterile injectables; proven leadership and collaboration skills. Preferred: experience with polymer depots, microspheres, nanosuspensions, in situ forming systems, device–drug integration, and global regulatory processes. HighValue: biologics and peptides, sterile injectable products, development stage from preclinical to commercialization, GxP compliance, cross-disciplinary collaboration, travel (~10%). WorkSetup: not specified.