Principal Scientist, Long-Acting Injectable Sterile Product Development

Principal Scientist role leading long-acting injectable formulation development across small molecules, peptides, and biologics. Provides technical leadership on multidisciplinary teams to advance LAI strategy, formulation design, and lifecycle management from preclinical through commercialization.

Responsibilities

• Provide scientific leadership for design, development, and lifecycle management of long-acting injectable drug products
• Lead formulation and delivery strategy development, including selection and optimization of release mechanisms and excipient systems
• Design and interpret studies on release kinetics, drug-excipient interactions, stability, and device compatibility
• Support early and late-stage development including manufacturing process selection, design space definition, and scale-up validation
• Partner with clinical, quality, regulatory, and manufacturing teams to define critical quality attributes and support submissions

Requirements

• Ph.D. with 7+ years industry experience in pharmaceutics or related discipline
• Deep expertise in parenteral drug product and long-acting injectable formulation development
• Strong understanding of controlled-release mechanisms, drug-polymer interactions, and formulation stability
• Experience with Quality by Design principles and DOE approaches to development
• Demonstrated ability to lead cross-functional teams and mentor senior-level scientists
• Working knowledge of CMC regulatory expectations for parenteral and extended-release products
• Experience supporting process scale-up, validation, and technology transfer for sterile injectables