Senior Scientist, Drug​/Device Combination Products; Hybrid

Position: Senior Scientist, Drug/Device Combination Products (Hybrid)
** Job Description*
* Our company's Combination Product Characterization and Verification (CPCV) 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 leverage a broad range of cutting-edge analytical instruments and methodologies, including  _in silico_  modeling, to develop a fundamental understanding of device material and functional properties, with a focus on intravitreal injection combination product development.

The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.

Our company 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 our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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:*
* B.S., M.S or Ph.D.. in Material Science, Chemistry 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 testing and troubleshooting skills able to work independently in a laboratory setting

+ Strong background in optical imaging, mechanical testing, particle analysis and measurement equipment and techniques. Including, but not limited to, advanced imaging, 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 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

*
* Required Skills:

*
* Analytical Method Development, Computed Tomography (CT) Scan, Creativity, Cross-Functional Collaboration, Cross-Functional Communications, External Partners, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Materials Science, Mechanical Design, Mechanical Engineering, Mechanical Testing, Medical Devices Design, Method Validation, Microscopies, Product Development, Project Leadership, Prototyping, Quality Management, Risk Management, Statistical Analysis, Teamwork, Technical Writing, Tensile Strength Testing

** Preferred

Skills:

*
* Current Employees apply HERE ($6687.htmld)

Current…