Associate Principal Scientist, Combination Product Characterization

Merck • Rahway, NJ

2d • Hybrid

About The Position

Our Company's 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.
They 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 are often assemblages of glass pre-filled syringes, injection molded plastic components driving delivery of a drug, typically though mechanical or electro-mechanical means. Examples include, but not limited to, autoinjectors and inhalers.
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.

Requirements

• Ph.D. in Mechanical Engineering or equivalent field is required.
• A minimum of a Ph.D. plus 4 years of device design and engineering evaluation experience.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a laboratory setting
• Experience with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Strong cross-functional communication – communicating complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding and to support project timelines.
• Development experience in risk-oriented, regulated environments
• Development project leadership with a proven track record collaborating with and managing external vendors/research partners.

Nice To Haves

• 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, ISO 11608 Needle-based injection system for medical use.
• Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle.
• Additional familiarity/experience with the following 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

Benefits

• 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.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree