Sr. Scientist, Drug/Device Combo Products (Onsite)

MSD • Rahway, NJ

21h • $117,000 - $184,200 • Onsite

About The Position

The Sr. Scientist will technically evaluate drug delivery device technology platforms across the company’s pipeline to identify risks and opportunities for improvement. The role uses analytical instruments, methods, and data analysis to develop a fundamental understanding of device material and functional properties. Platforms may include injection-molded plastic components that deliver drugs mechanically or electromechanically, such as injector pens, on-body injectors, and inhalers. Evaluations may involve limited material and require creative approaches.

The position develops and validates mechanical tests, conducts engineering and design verification studies, supports stability and validation protocols, and provides recommendations for product or design changes. It collaborates with colleagues and trains junior staff in instrumentation operation and data analysis. The position is onsite in Rahway, New Jersey.

Requirements

• B.S., M.S., or Ph.D. in Mechanical Engineering or an equivalent field.
• A minimum of a Ph.D., an M.S. plus 4 years, or a B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.
• Exceptional mechanical testing and troubleshooting skills, with the ability to work independently in a laboratory setting.
• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.
• Deep technical understanding of test method development and qualification/validation techniques.
• Fluency with mechanical testing, imaging, and measurement equipment and techniques, including force/tension/compression testing, rheometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience with 3D CAD (e.g., Solidworks), geometric tolerancing, and stack-up analysis.
• Ability to document test cases following Good Documentation Practices, analyze them, and provide comprehensive feedback and recommendations for product or design changes.

Nice To Haves

• Experience operating and interpreting data from Instron, XRCT, microscopes, vision systems (e.g., Keyence/Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers.
• Experience developing and validating innovative mechanical tests, including engineering studies, design verification protocols, stability studies, and validation protocols.
• Experience ensuring measurement systems analysis for finished-product performance test methods as needed in technology transfer or lifecycle work.
• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, and ISO 11608 Needle-based injection system for medical use.
• Additional industry-related familiarity or experience with 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry on Container Closure Systems for Packaging Human Drugs & Biologics, ISO 11040, ISO 10993, and PSCS.

Responsibilities

• Technically interrogate drug delivery device platforms across the company’s pipeline to identify risks and opportunities for improvement.
• Use analytical instruments, methods, and data analysis and interpretation to understand device material and functional properties and attributes.
• Perform mechanical testing and troubleshooting independently in a laboratory setting.
• Train junior staff on instrumentation operation, data analysis and interpretation, and statistical analysis best practices.
• Develop, validate, and qualify test methods, including engineering studies, design verification protocols, stability studies, and validation protocols.
• Select appropriate acceptance criteria and sampling plans and ensure measurement systems analysis for finished-product performance test methods as needed in technology transfer or lifecycle work.
• Collaborate on ideation and prototyping, including development of fixtures for functional testing.
• Document test cases according to Good Documentation Practices, analyze results, and provide comprehensive feedback and recommendations for product or design changes.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, 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