Scientist - II (Associate) - PA/NJ Only

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Scientist - II
Location: Rahway, NJ
Duration: 12 Months

Description:

***. Rahway, N.J., U.S.A. known as Client in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Client has codified its legacy for over a century. Client's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Client is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Client Research Laboratories is a true scientific research facility of tomorrow and will take Client's leading discovery capabilities and world-class small molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment.
Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Scientist, Device and Combination Product Test

The Client Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused Scientist focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products).
This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting Client's pipeline to identify risks (i.e. when/why/how will the device fail) 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 though mechanical (i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) 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.

Qualification:
Education Requirement (minimum):

Required Experience and Skills:

A minimum of M.S., or B.S. plus 1-3 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.
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 analyze test cases and provide 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, and drop shape analyzers.
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. Ensure 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: