Principal Scientist, Long-Acting Injectable Sterile Product Development
Core
Leading the design, development, and lifecycle management of long-acting injectable (LAI) drug products, including depot formulations and sustained-release systems, from preclinical through commercialization.
Role type
Principal Scientist, Long-Acting Injectable Sterile Product Development
Builds
Robust and scalable parenteral dosage forms and delivery solutions for small molecules, peptides, and biologics.
Domain
Pharmaceutical Sciences / Drug Delivery / Parenteral Formulations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LAI formulation science, Controlled-release mechanisms, Drug-polymer interactions, QbD principles, DOE approaches, Process scale-up, Technology transfer, CMC regulatory submissions, Cross-functional leadership, Mentoring
Preferred skills
Polymer depots, Microspheres, Nanosuspensions, In situ forming systems, Device-drug integration, Global regulatory filings, Scientific publications
Technologies
Polymer-based depots, Suspensions, Microspheres, In situ forming systems, Prefilled syringes
Responsibilities
Lead LAI formulation and delivery strategy development; Design and interpret studies to understand release kinetics and stability; Support early- and late-stage development programs including manufacturing process selection; Partner with Clinical, Quality, and Regulatory teams to define CQAs and CPPs; Provide scientific oversight and mentoring to junior scientists; Maintain awareness of emerging LAI technologies.
Seniority
Principal, strategic technical leadership with hands-on formulation science
