Principal Scientist, Long-Acting Injectable Sterile Product Development

Overview

The Sterile Product Development group is responsible for the development of parenteral dosage forms, including long‑acting injectables (LAIs), across small molecules, peptides, and biologics from preclinical development through commercialization. This principal scientist‑level role focuses on LAI formulation and development strategy, shaping depot formulations, extended‑release systems, and injectable sustained‑delivery technologies.

• Serve as a principal‑level LAI formulation scientist, providing scientific leadership for design, development, and lifecycle management of depot, sustained‑release, and controlled‑delivery parenteral dosage forms.
• Lead LAI formulation and delivery strategy development, including selection and optimization of release mechanisms (polymer‑based depots, suspensions, microspheres, in situ forming systems), excipient systems, and delivery approaches to meet target product profiles.
• Provide strategic technical leadership on cross‑functional program teams, ensuring alignment of formulation, drug substance properties, delivery system performance, container/closure systems, manufacturability, and clinical use considerations throughout development.
• Design and interpret studies to understand and control release kinetics, stability, and performance, covering drug–excipient and drug–polymer interactions, in vitro and in vivo performance relationships, physical stability, aggregation, particle size control, syringe ability, injectability, and device compatibility.
• Support early‑ and late‑stage development programs, including selection of scalable manufacturing processes for LAIs, definition of formulation and process design space, support for clinical and commercial process scale‑up and validation, and technology transfer to GMP manufacturing facilities.
• Partner closely with Clinical, Non‑Clinical, Quality, Regulatory, Manufacturing, and Engineering teams to define critical quality attributes (CQAs) and critical process parameters (CPPs) relevant to LAI performance, support clinical strategy through formulation design and risk mitigation, and contribute to CMC regulatory submissions and health authority interactions.
• Provide scientific oversight, mentoring, and capability development for junior scientists in LAI formulation science, experimental design, and data‑driven decision making.
• Maintain awareness of emerging LAI technologies and delivery platforms, contributing to internal capability assessments, external collaborations, and innovation initiatives aligned with the portfolio and organizational strategy.

• Ph.D. with 7+ years industry experience, or
• M.S. with 10+ years industry experience, or
• B.S. with 14+ years industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline.

• Deep expertise in parenteral drug product development, with demonstrated experience in long‑acting injectable or sustained‑release formulations.
• Strong scientific understanding of controlled‑release mechanisms and LAI delivery systems, drug–polymer and drug–excipient interactions, formulation stability, and performance characterization.
• Experience applying Quality by Design (QbD) principles and DOE approaches to formulation and process development.
• Experience supporting process scale‑up, validation, and technology transfer for sterile injectable products.
• Working knowledge of CMC regulatory expectations for parenteral and extended‑release products, including development‑stage and commercial submissions.
• Demonstrated ability to lead cross‑functional teams, influence strategy, and communicate complex scientific concepts clearly.
• Proven mentoring and scientific leadership skills at the senior/principal level.

• Experience with LAI‑specific platforms, such as polymer depots, microspheres, nanosuspensions, or in situ forming systems.
• Experience with device–drug product integration, including prefilled syringes or delivery systems relevant to LAIs.
• Understanding of clinical and patient‑centric considerations…