Sr. Scientist, Drug/Device Combo Products (Onsite)
MSD
Summary
This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device's material and functional properties and attributes.
Job description
Role Summary
This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device's material and functional properties and attributes.
Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically through mechanical or electro-mechanical means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.
Education Requirement
B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.
Required Experience and Skills
- A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.
- Exceptional mechanical testing and troubleshooting skills able 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 but not limited to force/tension/compression testing, rheometry, and microscopy.
- Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
- Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
- Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.
Preferred Experience and Skills
- Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers.
- Develop innovative 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.
- 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, Medical Electrical Equipment - EN 60601, Medical Device Software Standard - IEC 62304, ISO 11608 Needle-based injection system for medical use.
- Additional familiarity/experience with the following industry related knowledge is a plus: 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.
Requirements
- B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field
- A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience
- Exceptional mechanical testing and troubleshooting skills able 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 in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis
- Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes
- Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems, Bouncer, drop shape analyzers, spectrophotometers, and rheometers
- Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols
- Ensures measurement systems analysis (MSA's) for all finished product performance test methods
- Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
- Familiarity with ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
MSD, known as Merck Sharp & Dohme outside the United States and Canada, is a global research-intensive biopharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891, the company has established itself as one of the world's leading pharmaceutical corporations with a rich history spanning over 130 years. MSD operates as the international division of Merck & Co., Inc., focusing on the discovery, development, manufacturing, and marketing of innovative medicines, vaccines, biologic therapies, and animal health products. The company's extensive portfolio includes groundbreaking treatments in oncology, infectious diseases, cardiology, diabetes, and vaccines, with notable products such as Keytruda (pembrolizumab) for cancer immunotherapy, Gardasil for HPV prevention, and Januvia for diabetes management. MSD maintains a strong commitment to research and development, investing significantly in scientific innovation to address unmet medical needs worldwide. With approximately 75,000 employees globally, the company operates through four main segments: pharmaceuticals, animal health, healthcare services, and strategic alliances. MSD's mission centers on using leading-edge science to save and improve lives around the world, guided by the principle that medicine is for people, not profits.