Senior Scientist​/Engineer, Medical Device and Combination Products, Analytical

Job Description

Senior Scientist/Engineer, Medical Device and Combination Products, Analytical

The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global-human-health portfolio and closely partner with various Packaging or Device Technology engineering groups, packaging sites, and partner analytical groups.

The CPDA is located at our Company’s large research and manufacturing West Point, PA location, where our packaging & device laboratories are established.

The CPDA is seeking a Sr. Scientist/Engineer who, as an individual contributor, can focus on the following responsibilities & objectives:

• Define and deliver impactful science to our MDCP portfolio programs in both late-stage development and commercial manufacturing in the context of characterization, design verification, technical risk assessment, changes, and investigations.
• Represent the CPDA on cross functional teams effectively as a trusted collaborator, clear communicator (verbal and written) and analytical technical leader, who asks critical questions to help define direction and takes actions to deliver.
• Innovate and improve our analytical approaches to interrogate critical functionality, geometry and function and failure modes relevant to manufacturing, packaging, distribution or patient/provider use.
• Deliver sharp problem solving through theoretical & experimental acumen [breadth and depth] and creative thinking.
• Recognize technology gaps and drive to industry-leading fundamental understanding, as needed, in the realm of engineered materials, component/device designs, and function through depth in areas such as tribology, solid-mechanics, advanced material science, mechanical simulation and human factor studies.
• Broaden and deepen your technical proficiency through learning and collaboration within the full CPDA, which includes primary packaging & protective packaging technology responsibilities, and our embedded sister group, which is a comprehensive physical materials science laboratory supporting (bio) pharmaceutical drug product commercialization and manufacturing.

• Ph.D. in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Materials Science & Engineering, or closely related field.

• Demonstrated record of experimental research and publication in peer-reviewed journal(s)

• Proficiency with applied mechanical testing and material imaging. Advanced examples would be ability to develop non-standard methods for multi-axis multi-phase mechanical characterization and quantitative optical or x-ray tomographic imaging for precise dimensioning.
• Medical device development with practical understanding of Design Controls (21 CFR 820.30) and relevant industry standards.
• Proficiency in Device Characterization, for functionality and robustness.
• Design Verification strategy & execution with respect to selection, development & validation of methods as well as principled design of stability studies, acceptance criteria and protocols.
• Successful interdisciplinary research or manufacturing team projects.
• Research involving solid mechanics or tribology, engineering/ processing of polymers, ceramics or glass, advanced material science, or mechanical simulation.

Analytical Method Development, Chemical Synthesis, Chromatography, Flow Cytometry, Mass Spectrometry Based Proteomics, Materials Engineering, Medical Devices, Medical Devices Design, Packaging, Packaging Engineering, Packaging Processes, Plastics Engineering, Plastics Technology, Polymers Technology, Process Analytical Technology (PAT), Product Engineering, Protein Chromatography, Spectroscopy, Synthetic Biology

Current Employees apply HERE

Current Contingent Workers apply HERE

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