Associate Principal Scientist, Biopharmaceutics

Merck • Rahway, NJ

5d • $142,400 - $224,100

About The Position

The Associate Principal Scientist will lead biopharmaceutics strategy for subcutaneously administered biologics across the development pipeline, from early formulation screening through late-stage commercialization and lifecycle management. The role collaborates closely with formulation, analytical, device engineering, pharmacokinetics, and clinical pharmacology teams, applying mechanistic principles, quantitative translational modeling, and experimental frameworks to evaluate SC absorption, formulation and device compatibility, product bridging, and immunogenicity risk. The position requires scientific rigor and matrix leadership to de-risk clinical delivery and inform program decisions at key governance milestones.

The role defines integrated experimental and modeling strategies for formulation, dose volume, injection site, and device decisions; translates preclinical findings and assesses exposure variability; and evaluates the potential effects of product quality attributes, formulation, particles, aggregates, and delivery conditions on local tolerability, pharmacokinetics, and immunogenicity. It also communicates recommendations and risks in program and governance forums, supports regulatory submissions and health authority materials, develops predictive tools and experimental approaches, mentors scientists, and contributes to external scientific engagement.

Requirements

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical or Biomedical Engineering, or a related scientific discipline with at least 3 years of relevant experience; alternatively, a master's degree in a relevant discipline with at least 8 years of relevant industry experience.
• Demonstrated expertise in biologics drug product development, particularly 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 such as vial to pre-filled syringe or autoinjector, and formulation bridging.
• Working understanding of how biologic quality attributes, including aggregation, opalescence, viscosity, and particle formation, interact with delivery devices and may affect clinical immunogenicity or ADA.
• Strong critical thinking and problem-solving skills, including 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.

Nice To Haves

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

Responsibilities

• Define integrated experimental and modeling strategies to guide formulation, dose volume, injection site, and device decisions across development.
• Apply mechanistic and quantitative approaches to translate preclinical findings, assess exposure variability, and support formulation, device, process, scale, and site changes.
• Evaluate how product quality attributes, formulation, particles, aggregates, and delivery conditions may affect local tolerability, pharmacokinetics, and immunogenicity.
• Communicate risks and recommendations at program and governance forums.
• Author or review relevant regulatory submissions and health authority briefing materials.
• Develop predictive tools and experimental approaches.
• Mentor scientists and contribute to external scientific engagement.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree