Assoc. Scientist, Research Pharmacy

Job Description

Our Company's Device Development & Technology (DD&T) Team is seeking a hands‑on, lab‑focused engineer focused on the characterization and testing of devices (components, sub‑assemblies, and full devices) and combination products (drug‑delivery products). 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/why/how will the device fail) and opportunities for improvement.

They will utilize a wide variety of cutting‑edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection‑molded plastic components driving delivery of a drug, typically through mechanical (i.e. compress/torsion spring, compressed gas) or electro‑mechanical (i.e. DC motor and battery driving a gearbox) means.

Examples include, but not limited to, injector pens, on‑body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

• B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.

• Design, engineering, and mechanical testing/test method development experience.
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
• Familiarity of test method development and qualification/validation/transfer techniques.
• Familiarity with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack‑up analysis.
• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

• Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, and drop shape analyzers.
• Develop innovative 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.
• 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
  • ISO 11608

• Accountability
• Analytical Thinking
• Biochemical Analysis
• Biomedical Engineering
• Chemical Engineering
• Clinical Manufacturing
• Creativity
• Data Analysis
• Dosage Forms
• Evaluating New Technologies
• Medical Knowledge
• Patent Analysis
• Pharmaceutical Production
• Product Development
• Project Reviews
• Scientific Research
• Teamwork
• Technical Problem‑Solving

$71,900.00 - $

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

Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a Hybrid work consisting of three total days on‑site…