Sr. Scientist, Preclinical Dev.

Merck • Rahway, NJ

1d • Hybrid

About The Position

The Biologics & Biopharmaceutics team is an integrated team responsible for the development and successful registration of new drug products. Formulation activities focus on the development of non-oral dosage forms spanning preclinical toxicology studies through commercialization. We ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. Biopharmaceutics scientists proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico Physiologically Based Pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community.
Our team is looking for a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment across delivery of small molecule, peptides and biologic modalities. The successful candidate will be responsible for representing the biopharmaceutics team in drug product development teams, driving the biopharmaceutics strategy, while helping to develop the next generation of physiologically-based modeling and simulation tools.

Requirements

• Strong foundation in pharmacokinetics and PK modeling principles.
• Working knowledge of formulation and biopharmaceutics principles relevant to small molecules, peptides, and/or biologics.
• Effective communication with the ability to present scientific data clearly, support decision-making, and solve complex problems.
• Demonstrated ability to work effectively with interdisciplinary and matrix team environments.
• Self-motivated with strong ownership, accountability, and follow-through.
• Scientific contributions through publications and conference presentations in biopharmaceutics, PK, biologics or related fields.

Nice To Haves

• Hands-on experience with absorption modeling tools such as Simcyp, GastroPlus, Phoenix, PK-Sim, or related platforms.
• Direct experience modeling or characterizing subcutaneous absorption of biologics, including monoclonal antibodies, fusion proteins, peptides, or related modalities.
• Experience with computational and data analysis tools such as MATLAB, Python, R, Phoenix, or similar software.
• Familiarity with formulation, device, and delivery considerations for subcutaneous administration, including injectability, stability, and compatibility.
• Experience designing, executing, or interpreting in vivo PK studies and applying findings to translational assessments.
• Familiarity with specialized dosage forms or advanced delivery systems, including extended release, inhaled, or other non-oral platforms.

Responsibilities

• 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.
• Influence formulation and delivery strategies for parenterally administered biologic modalities and protein therapeutics by considering absorption kinetics, stability and immunogenicity
• 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.
• Actively contribute to internal and external innovation in biopharmaceutics and quantitative modeling through scientific collaboration and capability development.
• 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.
• Collaborate closely with formulation scientists, analytical teams, clinical pharmacology, and device/delivery experts to advance biologic programs and de-risk bridging strategies.
• Communicate scientific findings and recommendations clearly to cross-functional teams, governance forums, and external scientific audiences.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior