Sr. Scientist, Drug/Device Combo Products

Job Description

Our Company Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company's pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. In this role, the successful candidate will utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices’ material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies. These drug delivery device technology platforms can be but not limited to, pre-filled syringes, auto injectors, onbody injectors and inhalers.  The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.

Our Company 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. Our Company's Research Laboratories is a true scientific research facility of tomorrow and will take our Company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

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.

Education Requirement (minimum):

• 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 testing/test method development experience.

• Solid imaging and image post-processing experience

• Solid testing and troubleshooting skills able to work independently in a laboratory setting

• Experience with mechanical testing, and measurement equipment and techniques. Including, but not limited to, tensile/compression testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.

• Excellent collaboration, ideation, and prototyping skills, including facilitating design brainstorming sessions, developing proof of concepts, working prototypes and conducting functional testing.

• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.

• Fluency in finite element analysis (FEA) and computational fluid dynamics (CFD).

• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).

• Liaises closely with other partner functions including QA (Quality), Analytical Sciences, CROs and others to support project timelines.

• Cross-functional communication – communicating complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding.

• Development experience in risk-oriented, regulated environments

• Development project leadership with a proven track record collaborating with and managing external vendors/manufacturers.

Preferred Experience and Skills:

• 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

#eligibleforERP

Current Employees apply HERE

Current Contingent Workers apply