Principal Scientist, Combination Product Physics Based Modeling and Simulation Combination Products

Merck; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Merck is seeking a Principal Scientist to lead physics-based modeling and simulation within the Device Product Assessment and Innovation team in Device Development and Technology. The role connects device physics with translational PK/PD insights, guiding specifications and reducing physical testing through first-principles modeling.

You will drive standards for model verification, validation, and uncertainty, collaborate with translational and PK/PD experts, and mentor scientists across

Qualifications

• Advanced physics-based modeling of device mechanics and PK/PD translation.
• Experience with regulatory submissions and quality systems is a plus.
• Ability to mentor scientists in a matrixed organization.
• Strong communication of technical trade-offs to stakeholders.

Responsibilities

• Set cross-program modeling strategy linking device physics with translational PK/PD insights.
• Lead first-principles modeling of formulation mechanics, flow paths, actuation, and tissue interactions.
• Set model development, verification, validation, and uncertainty standards.
• Partner with translational and PK/PD experts to integrate delivery-environment properties with exposure and biology.
• Advance reusable models and data workflows across partner groups; mentor scientists.
• Lead modeling contributions to design controls, validation protocols, and regulatory submissions; represent the function in forums.

Skills

Cross-functional leadership

Mentoring

Uncertainty quantification

Independent judgment

Education

PhD in Engineering

Tools

MATLAB

ABAQUS

ANSYS

COMSOL

Python

C++

Job description

Job Description

We are seeking a Principal Scientist to lead physics-based modeling and simulation within the Device Product Assessment and Innovation team in Device Development and Technology. The role connects drug delivery device physics with translational modeling of the delivery environment, tissue interactions, and pharmacokinetics/pharmacodynamics (PK/PD), partnering with teams to link formulation, device performance, and biological response. The role sets cross-program strategy, advances shared data and decision science capabilities, and provides independent scientific judgment, cross-functional influence, and scientific mentoring.

Responsibilities

• Set cross-program modeling strategy linking device physics with physiologically representative delivery environments and translational PK/PD insights, aligned with portfolio priorities and manufacturing digital twin capabilities.
• Lead first-principles modeling of formulation mechanics, flow paths, actuation, and tissue interactions; integrate tissue phantoms and delivery-environment digital twins with translational partners to guide specifications and reduce physical testing.
• Set model development, verification, validation, and uncertainty standards; oversee scientific review for credible, reproducible, fit-for-purpose results.
• Partner with translational and PK/PD experts to integrate delivery-environment properties, biometrics, formulation attributes, and device performance with exposure and biological response; assess preclinical-to-human translation and inform governance decisions.
• Advance reusable models, shared data workflows, decision science, and appropriate AI methods across the three partner groups; prioritize capability investments and external collaborations, and mentor scientists.
• Lead modeling contributions to design controls, validation protocols, and regulatory submissions with Quality and Regulatory; represent the function in scientific forums, publications, conferences, and consortia, as appropriate.

Qualifications

• Bachelor's + 12 years, master's + 9 years, or PhD + 6 years of relevant experience in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline.
• Extensive physics-based modeling and simulation experience addressing complex engineering or scientific problems; ability to transfer methods across applications. Device, drug delivery, or combination product experience is preferred, not required.
• Advanced simulation and programming skills (e.g., MATLAB, ABAQUS, ANSYS, COMSOL, Python, C++), including method selection and robust, reusable workflows.
• Demonstrated cross-program or platform scientific leadership, independently resolving complex problems and evaluating model credibility and uncertainty to guide decisions.
• Demonstrated cross-functional and senior-stakeholder influence, clear communication of technical trade-offs, and scientific mentoring in a matrixed environment.
• Experience with rigorous model verification, validation, uncertainty assessment, and technical documentation; ability to build working knowledge of device development expectations in partnership with domain experts.

Required Skills

• Biomedical Engineering
• Combination Products
• Cross-Functional Communications
• Drug Delivery
• Finite Element Analysis (FEA)
• Human Factor Engineering
• Mechanical Engineering
• Mechanical Testing
• Medical Device Quality Systems
• Next Generation Science Standards
• Pharmacokinetics
• Physics Simulation
• Process Development Engineering
• Risk Management
• Simulation Programming

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.