Biopharmaceutics Strategy Lead Subcutaneous Delivery

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Principal Scientist to lead biopharmaceutics strategy for subcutaneously administered biologics across the pipeline, from early formulation screening to lifecycle management.

You will collaborate with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply modeling and experimental frameworks to evaluate SC absorption, device compatibility, and immunogenicity risk.

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 3+ years of industry experience.
• Alternatively Master’s with 8+ years industry experience.
• Strong expertise in biologics drug product development and SC pharmacokinetics.
• Experience leading cross-functional matrix teams.

Responsibilities

• Lead SC Biopharmaceutics Strategy: Define integrated experimental and modeling strategies to guide formulation, dose volume, injection site, and device decisions across development.
• Drive Translation and Product Bridging: Apply mechanistic and quantitative approaches to translate preclinical findings, assess exposure variability, and support formulation, device, process, scale, and site changes.
• Assess Immunogenicity and Bio performance Risk: Evaluate how product quality attributes, formulation, particles, aggregates, and delivery conditions may affect local tolerability, pharmacokinetics, and immunogenicity.
• Influence Governance and Regulatory Strategy: Communicate risks and recommendations at program and governance forums and author or review relevant regulatory submissions and health authority briefing materials.

Skills

Biopharmaceutics

Drug product development

Translational PK

Matrix leadership

Regulatory submissions

Immunogenicity risk assessment

Subcutaneous absorption

Pharmacokinetics (PK)

Mechanistic modeling

Translational modeling

Education

Ph.D. in Pharmaceutical Sciences

Master’s degree in a relevant discipline

Tools

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Job description

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Principal Scientist to lead biopharmaceutics strategy for subcutaneously administered biologics across the pipeline, from early formulation screening to lifecycle management.

You will collaborate with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams to apply modeling and experimental frameworks to evaluate SC absorption, device compatibility, and immunogenicity risk.