• 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

• 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

• 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• 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

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

$117,000.00 - $184,200.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.Company.com/us/en/compensation-and-benefits