Sr. Scientist, Biopharmaceutics

Merck Merck · Pharma · NJ

The Senior Scientist, Biopharmaceutics role at Merck focuses on developing and registering new drug products, specifically non-oral dosage forms. The role involves representing the biopharmaceutics team in drug product development, driving biopharmaceutics strategy, and developing next-generation physiologically-based modeling and simulation tools. Key responsibilities include identifying biopharmaceutics risks, influencing formulation strategies, developing quantitative absorption models, and contributing to internal and external innovation in biopharmaceutics and quantitative modeling.

What you'd actually do

  1. Proactively identify key biopharmaceutics risks at each stage of drug product development for biologics, peptides, and small molecules through rigorous, integrated hypothesis‑driven assessments, driving the development of in vitro–in vivo relationships (IVIVR) and strengthening preclinical‑to‑clinical translation of formulation bioperformance.
  2. Influence formulation and delivery strategies for parenterally administered biologic modalities and protein therapeutics by considering absorption kinetics, stability and immunogenicity
  3. Develop and apply quantitative absorption models to support formulation decisions, bioperformance risk assessment, IVIVR development, and clinically relevant specification setting across oral and parenteral drug products.
  4. Actively contribute to internal and external innovation in biopharmaceutics and quantitative modeling through scientific collaboration and capability development.
  5. Contribute to biopharmaceutics strategies development across administration routes, including oral dissolution and absorption, as well as subcutaneous delivery considerations, such as lymphatic uptake, interstitial transport, enzyme-mediated degradation, and formulation effects on absorption.

Skills

Required

  • Adaptability
  • Biopharmaceutics
  • Communication
  • Data Analysis
  • Dosage Forms
  • Innovative Thinking
  • PBPK Modeling
  • Pharmacokinetics

Nice to have

  • Biopharmaceuticals
  • Dissolution Testing
  • Drug Delivery
  • Drug Product Development
  • Formulation Development
  • Regulatory Submissions
  • Simcyp
  • GastroPlus
  • Phoenix
  • PK-Sim
  • MATLAB
  • Python
  • R
  • subcutaneous absorption of biologics
  • monoclonal antibodies
  • fusion proteins
  • peptides
  • in vivo PK studies

What the JD emphasized

  • PhD in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, or a related field with 0–3 years of experience.
  • Master’s degree in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, or a related field with at least 5 years of industry experience.
  • Strong foundation in pharmacokinetics and PK modeling principles.
  • Working knowledge of formulation and biopharmaceutics principles relevant to small molecules, peptides, and/or biologics.
  • Scientific contributions through publications and conference presentations in biopharmaceutics, PK, biologics or related fields.