Principal Scientist, Long-Acting Injectable Sterile Product Development
Merck · Rahway, NJ
ResearchFull-time$173k–$273kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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