Senior Scientist, Combination Product Characterization; Onsite

Position: Senior Scientist, Combination Product Characterization (Onsite)
** Job Description*
* ** Senior Scientist, Combination Product Characterization*
* 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 pre-filled syringe and auto injector 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 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 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 (minimum):*
* + B.S., M.S or Ph.D.. in Mechanical Engineering, Material Science 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 and mechanical testing, including advanced imaging techniques, tensile and 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

PSCS

eligibleforERP

*
* Required Skills:

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* Analytical Method Development, Analytical Method…