Biopharmaceutics Subcutaneous Strategy Lead

Merck; New Jersey; On-site; USD 140,000 - 220,000; Full time

Job summary

Merck is seeking an Associate Principal Scientist to lead the biopharmaceutics strategy for subcutaneously administered biologics, spanning from early formulation screening to lifecycle management.

You will collaborate with formulation, analytical, device engineering, PK, and clinical pharmacology teams to apply mechanistic principles, modeling, and experimental frameworks to optimize SC absorption and immunogenicity risk.

Qualifications

• PhD with 3+ years of industry experience or MS with 8+ years in a relevant field.
• Expertise in biologics drug product development and SC absorption.
• Experience leading cross-functional matrix teams and translating complex data into decisions.

Responsibilities

• Define integrated experimental and modeling strategies for formulation, dose volume, injection site, and device decisions across development.
• Translate preclinical findings, assess exposure variability, and support formulation, device, process, and site changes.
• Evaluate immunogenicity risk related to quality attributes, delivery conditions, and pharmacokinetics.
• Communicate risks and recommendations at governance forums and support regulatory submissions.
• Develop predictive tools, mentor scientists, and contribute to external scientific engagement.

Skills

Biopharmaceutics

Subcutaneous absorption

Translational PK

Matrix leadership

Mechanistic modeling

Regulatory submissions

Device interactions

Education

PhD in Pharmaceutical Sciences

Master's degree in related field

Tools

GastroPlus

Simcyp

Phoenix WinNonlin

PK-Sim

MATLAB

Python/R

Job description

Merck is seeking an Associate Principal Scientist to lead the biopharmaceutics strategy for subcutaneously administered biologics, spanning from early formulation screening to lifecycle management.

You will collaborate with formulation, analytical, device engineering, PK, and clinical pharmacology teams to apply mechanistic principles, modeling, and experimental frameworks to optimize SC absorption and immunogenicity risk.