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

Merck & Co.

Rahway (NJ)

Híbrido

USD 157.000 - 247.000

Jornada completa

Hace 6 días
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Descripción de la vacante

Merck & Co. in Rahway, NJ is seeking a Principal Scientist to lead physics-based modeling and simulation within the Device Product Assessment and Innovation team. You will connect device physics with translational PK/PD insights, guiding specifications and reducing physical testing across programs.

You will set standards for model verification, validation, and uncertainty, mentor scientists, and collaborate with teams to inform governance decisions and external collaborations.

Formación

  • Extensive physics-based modeling and simulation experience across engineering problems.
  • Device, drug delivery, or combination product experience preferred but not required.
  • Advanced simulation and programming skills with reusable workflows.

Responsabilidades

  • Set cross-program modeling strategy linking device physics with translational PK/PD insights.
  • Lead first-principles modeling of formulation mechanics, flow paths, and tissue interactions.
  • Set model development, verification, validation, and uncertainty standards; ensure credible results.
  • Collaborate with translational and PK/PD experts to integrate delivery properties and biology.
  • Advance reusable models, data workflows, and decision science across partner groups; mentor scientists.
  • Contribute to design controls, validation protocols, and regulatory submissions with QA/R&D.

Conocimientos

Biomedical Eng
Combination Products
Cross-Functional Comms
Drug Delivery
FEA
Human Factor Eng
Mechanical Eng
Mechanical Testing
Device Quality Systems
Next Gen Sci Standards
Pharmacokinetics
Physics Simulation
Process Development Eng
Risk Management
Simulation Programming

Educación

Herramientas

MATLAB
ABAQUS
ANSYS
COMSOL
Python
C++

Descripción del empleo

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
Preferred Skills

No preferred skills listed.

US and Puerto Rico Residents Only

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.

Learn more about your rights, including under California, Colorado and other US State Acts

Primary Location

USA - New Jersey - Rahway

Salary Range

$156,900.00 - $247,000.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional Location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional Location(s) Compensation Information

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

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