Senior LAI Formulation Scientist for Sterile Injectables

Merck; New Jersey; On-site; USD 140,000 - 190,000; Full time

Job summary

Merck in New Jersey is seeking an LAI formulation scientist to lead the design, development, and lifecycle management of long‑acting injectable parenteral dosage forms, including depot, sustained‑release, and in situ systems.

You will guide cross‑functional teams to define CQAs and CPPs, optimize release kinetics and stability, support process scale‑up and technology transfer, and mentor junior scientists while advancing regulatory interactions.

Qualifications

• Deep expertise in parenteral drug product development, with demonstrated experience in long‑acting injectable or sustained‑release formulations.
• Strong understanding of controlled‑release mechanisms and LAI delivery systems; drug‑polymer interactions; formulation stability and performance.
• Experience applying QbD principles and DOE to formulation and process development.
• Experience supporting process scale‑up, validation, and technology transfer for sterile injectables.
• Knowledge of CMC regulatory expectations for parenteral and extended‑release products.
• Ability to lead cross‑functional teams and communicate complex science clearly.

Responsibilities

• Lead LAI formulation and delivery development for programs, selecting release mechanisms and excipient systems.
• Provide technical leadership on cross‑functional teams to align formulation, drug substance, and delivery.
• Design studies to understand release kinetics, stability, and performance, including drug‑excipient interactions and syringeability.
• Support early‑ and late‑stage programs: scalable manufacturing processes, design space, tech transfer to GMP facilities.
• Collaborate with Clinical, Regulatory, Quality, and Manufacturing to define CQAs/CPPs and support regulatory submissions.
• Mentor junior scientists and monitor emerging LAI technologies and external collaborations.

Skills

Parenteral drug development

LAI formulations

QbD & DOE

Cross-functional leadership

Regulatory knowledge

Education

Ph.D. with 4+ years industry experience

MS with 8+ years

B.S. with 10+ years

Job description

Merck in New Jersey is seeking an LAI formulation scientist to lead the design, development, and lifecycle management of long‑acting injectable parenteral dosage forms, including depot, sustained‑release, and in situ systems.

You will guide cross‑functional teams to define CQAs and CPPs, optimize release kinetics and stability, support process scale‑up and technology transfer, and mentor junior scientists while advancing regulatory interactions.