Lead LAI Formulation Scientist for Long-Acting Injectables

Merck

New Jersey

On-site

USD 140,000 - 190,000

Full time

7 days ago

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Job summary

Merck in New Jersey seeks a Principal Scientist to lead long-acting injectable (LAI) formulation programs across depot and extended-release systems, from discovery through commercialization. You will provide scientific leadership, shape development strategy, and guide cross-functional teams across formulation, device compatibility, and manufacturing readiness.

The role requires mentoring senior scientists, driving QbD-enabled development, and delivering scalable processes while aligning with

Qualifications

Deep expertise in parenteral drug product development.
Knowledge of controlled-release mechanisms and LAI delivery systems.
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.

Responsibilities

Provide scientific leadership for LAI formulation design, development, and lifecycle management.
Lead LAI formulation strategy and optimize release mechanisms.
Collaborate with cross-functional teams to align CQAs and CPPs for LAI programs.
Design and interpret studies to understand release kinetics, stability, and performance.
Support clinical and commercial process scale-up and technology transfer to GMP manufacturing facilities.
Mentor junior scientists and promote data-driven decision making.