Senior Scientist, Parenteral LAI & PDC Formulations

MSD; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

MSD in Rahway, NJ is seeking a Senior Scientist in sterile product development to lead hands-on formulation and process development for long-acting injectables and peptide drug conjugates. You will design studies, interpret data, and provide technical recommendations within cross-functional teams.

The role emphasizes CMC considerations, scale-up, technology transfer to GMP facilities, and contribution to regulatory submissions, with collaboration across Clinical, Quality, Regulatory, and

Qualifications

• Ph.D. with 0 years industry experience, or M.S. with 4+ years industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline

Responsibilities

• Design, execute, and interpret formulation and process development studies for long-acting injectables and peptide drug conjugates, as well as conventional parenteral formulations.
• Evaluate approaches appropriate to each molecule and product, including polymer-based controlled-release systems and crystalline suspensions for long-acting injectables.
• Provide scientific input to cross-functional teams on formulation, drug substance properties, delivery system performance, container/closure compatibility, manufacturability, and clinical in-use considerations.
• Take technical responsibility for assigned workstreams, communicate findings and risks, and recommend next steps to project leads.
• Design, conduct, and interpret studies to understand formulation stability and product performance for long-acting injectables and peptide drug conjugates, including release kinetics where relevant: Drug–excipient and drug–polymer interactions
• In vitro and in vivo performance relationships
• Physical stability, solubility, aggregation, and particle size control, as appropriate to the formulation
• Syringe ability, injectability, and device compatibility
• Chemical stability of drug substances and formulated products, including peptide and conjugate integrity and formation of free drug in peptide drug conjugates
• Support early‑and late‑stage development programs, including: Experimental evaluation and recommendation of scalable manufacturing processes for long-acting injectables and peptide drug conjugates
• Characterization of formulation and process variables to support definition of design space
• Support for clinical and commercial process scale‑up and validation
• Technology transfer to GMP manufacturing facilities
• Collaborate with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues, contributing experimental data and scientific recommendations to: Identify and characterize critical quality attribute and critical process parameters relevant to LAI and PDC quality, stability, and performance
• Support clinical strategy through formulation design and risk mitigation
• Contribute to CMC regulatory submissions and health authority interactions
• Provide scientific leadership within defined workstreams by developing experimental plans, troubleshooting technical challenges, interpreting results, and sharing recommendations.

Skills

Chemistry

Data Analysis

Drug Delivery Technology

Drug Product Development

Experience Design

Flow Cytometry

High-Throughput Screening

Interpersonal Relationships

In Vitro Research

Molecular Biology Techniques

Multi-Color Flow Cytometry

Pharmaceutical Sciences

Preformulation

Process Development (PD)

Process Optimization

Education

Ph.D. with 0 years industry experience, or M.S. with 4+ years industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline

Job description

MSD in Rahway, NJ is seeking a Senior Scientist in sterile product development to lead hands-on formulation and process development for long-acting injectables and peptide drug conjugates. You will design studies, interpret data, and provide technical recommendations within cross-functional teams.

The role emphasizes CMC considerations, scale-up, technology transfer to GMP facilities, and contribution to regulatory submissions, with collaboration across Clinical, Quality, Regulatory, and