Associate Principal Scientist, Biopharmaceutics

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

Job Description

We are seeking an experienced Associate Principal Scientist to join our team and lead biopharmaceutics strategy for subcutaneously (SC) administered biologics across the pipeline-from early formulation screening through late-stage commercialization and lifecycle management. Working in close collaboration with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams, you will apply fundamental mechanistic principles, quantitative translational modeling, and experimental frameworks to evaluate SC absorption, formulation and device compatibility, product bridging, and immunogenicity risk. The ideal candidate will combine deep scientific rigor with strong matrix leadership to de-risk clinical delivery and influence program decision-making at key governance milestones.

Key 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.
• Advance Scientific Capabilities: Develop predictive tools and experimental approaches, mentor scientists, and contribute to external scientific engagement.

Qualifications:

Education Minimum Requirements:

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering, or related scientific discipline with 3+ years of relevant experience; OR
• Master's degree in a relevant discipline with 8+ years of relevant industry experience.

Required Experience and Skills:

• Demonstrated expertise in biologics drug product development with a strong focus on the mechanistic principles governing subcutaneous absorption, interstitial transport, and translational pharmacokinetics.
• Proven track record as a biopharmaceutics, formulation, or translational PK lead within cross-functional matrix development teams.
• Hands-on experience developing and executing biopharmaceutics risk assessments for product comparability, device transitions (e.g., vial to PFS/autoinjector), and formulation bridging.
• Working understanding of the interplay between biologic quality attributes (e.g., aggregation, opalescence, viscosity, particle formation), delivery devices, and clinical immunogenicity / ADA impact.
• Strong critical thinking and problem solving, with the ability to translate complex or incomplete data into clear development decisions.
• Outstanding oral, written, and presentation skills, with the ability to communicate technical complexity clearly to senior leadership and cross-functional teams.

Preferred Experience and Skills:

• Hands-on proficiency with mechanistic modeling and simulation platforms (e.g., GastroPlus, Simcyp, Phoenix WinNonlin, PK-Sim, MATLAB, or Python/R).
• Experience with high-concentration and/or large-volume SC biologic delivery, including co-formulation approaches or permeation-enhancing technologies.
• Direct experience authoring biopharmaceutics and comparability sections for regulatory filings (IND/BLA) or supporting agency briefing books.
• Prior experience evaluating device-biologic interactions and human factors considerations for pre-filled syringes, autoinjectors, or wearable delivery systems.
• Record of sustained scientific contributions, including peer-reviewed publications, invited presentations, or active participation in cross-industry consortia.

Required Skills:

• Biologics Drug Product, Biopharmaceutics, Bridging Strategies, Comparability, Drug Delivery, Formulation Characterization, Immunogenicity Risk Assessment, In Vitro-In-Vivo Translation, Matrix Leadership, Pharmacokinetics (PK), Pre-Filled Syringes & Autoinjectors, Regulatory Submissions, Subcutaneous Absorption, Translational Modeling.

Required Skills:

• Biopharmaceuticals, Cell Line Development, Clinical Pharmacology, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunogenicity, Molecular Biology, Pharmaceutical Formulations, Pharmaceutical Process Development, Pharmaceutical Sciences, Pharmacokinetics, Physical Characterization, Stable Cell Lines.