Merck · 18 hours ago
Associate Principal Scientist, Combination Product Characterization
USA - New Jersey - Rahway
Full-time
Hybrid
Senior Level, Lead/Staff
$142K/yr - $224K/yr
4+ years expMerck is a leading biopharmaceutical company committed to research and innovation. The Associate Principal Scientist will focus on device characterization and design, utilizing analytical methods to enhance drug delivery technologies.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company's pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement
Utilize a wide variety of cutting-edge analytical instruments and methods, including *in silico* modeling, to build fundamental understanding of the devices’ material and functional properties and attributes
Design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies
Qualification
Required
Ph.D. in Mechanical Engineering or equivalent field is required
A minimum of a Ph.D. plus 4 years of device design and engineering evaluation experience
Fluency in structural finite element analysis (FEA)
Solid testing and troubleshooting skills able to work independently in a laboratory setting
Experience with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy
Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis
Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA)
Strong cross-functional communication – communicating complex mechanical engineering information in layman's terms to facilitate cross-functional understanding and to support project timelines
Development experience in risk-oriented, regulated environments
Development project leadership with a proven track record collaborating with and managing external vendors/research partners
Preferred
Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use
Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle
21 CFR Part 4
21 CFR 211
FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics
ISO 13485
ISO 14971
ISO 11040
ISO 10993
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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