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

MSD • Rahway, NJ

3d • $117,000 - $184,200 • Onsite

About The Position

This position performs technical interrogation of drug delivery device technology platforms supporting the company’s pipeline to identify risks and opportunities for improvement. The scientist uses analytical instruments, methods, and data analysis and interpretation to develop an understanding of device material and functional properties and attributes. The platforms may include assemblages of injection-molded plastic components that deliver a drug mechanically or electromechanically, such as injector pens, on-body injectors, and inhalers. Work at this early evaluation stage may involve limited material and require creative approaches.

The role requires independent laboratory work, development and validation of mechanical tests, interpretation of results, and technical recommendations for product or design changes. The scientist also collaborates with colleagues and external partners, develops prototypes and fixtures, and may train junior staff in instrumentation operation and data-analysis practices.

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 and 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, and compression testing, rheometry, and microscopy.
• Strong collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience with 3D CAD such as SolidWorks, geometric tolerancing, and stack-up analysis.
• Ability to document work following Good Documentation Practices, analyze test cases, and provide feedback and recommendations for product or design changes.

Nice To Haves

• Experience operating and interpreting data from Instron, XRCT, microscopes, vision systems such as Keyence or Cognex, Bouncer, drop-shape analyzers, spectrophotometers, and rheometers.
• Experience developing innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols, with appropriate acceptance criteria and sampling plans.
• Experience ensuring measurement systems analysis for finished-product performance test methods for technology transfer or lifecycle activities.
• Experience with medical-device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, and ISO 11608.
• Familiarity or experience with 21 CFR Part 4, 21 CFR 211, FDA guidance for industry on container-closure systems for packaging human drugs and biologics, ISO 11040, ISO 10993, and PSCS.

Responsibilities

• Technically evaluate drug delivery device technology platforms supporting the company’s pipeline to identify risks and improvement opportunities.
• Use analytical instruments, mechanical tests, imaging, measurement techniques, and data analysis to characterize device materials and functional properties.
• Develop and qualify or validate test methods, including innovative mechanical tests and engineering studies.
• Train junior staff in instrumentation operation, data analysis and interpretation, and statistical analysis best practices.
• Collaborate on ideation, prototyping, and fixture development for functional testing.
• Document and analyze test cases in accordance with Good Documentation Practices and provide comprehensive feedback and recommendations for product or design changes.
• Develop and conduct engineering studies, design verification protocols, stability studies, and validation protocols, including selection of acceptance criteria and sampling plans.
• Ensure measurement systems analysis for finished-product performance test methods as needed for technology transfer or lifecycle activities.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate days
• Sick days
• Annual bonus eligibility
• Long-term incentive eligibility, if applicable

What This Job Offers

• Job Type: Full-time
• Career Level: Senior