Senior Scientist, Drug/device Combination Products (hybrid)

Merck Merck · Pharma · NJ

Seeking a scientist focused on device characterization and design for drug delivery platforms, involving technical interrogation, risk identification, and improvement opportunities. The role utilizes analytical instruments and methodologies, including in silico modeling, for understanding device material and functional properties, particularly for intravitreal injection combination products. Requires strong cross-functional collaboration, scientific leadership, and communication skills.

What you'd actually do

  1. Technical interrogation of drug delivery device technology platforms to identify risks and opportunities for improvement.
  2. 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.
  3. Focus on intravitreal injection combination product development.
  4. Effective cross functional collaboration skills.
  5. Demonstrated excellent scientific leadership.

Skills

Required

  • Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and testing/test method development experience
  • Testing and troubleshooting skills
  • Optical imaging
  • Mechanical testing
  • Particle analysis and measurement equipment and techniques
  • Advanced imaging
  • Tensile/compression testing
  • Surface characterization
  • X-ray computed tomography
  • Rheometry
  • Microscopy
  • Collaboration, ideation, and prototyping skills
  • Facilitating design brainstorming sessions
  • Developing proof of concepts
  • Working prototypes
  • Conducting functional testing
  • 3D CAD (e.g. Solidworks)
  • Geometric tolerancing and stack-up analysis
  • Design Failure Modes and Effect Analysis (FMEA, DFMEA)
  • Liaising with QA, Analytical Sciences, CROs
  • Cross-functional communication
  • Development experience in risk-oriented, regulated environments
  • Development project leadership
  • Collaborating with and managing external vendors/manufacturers

Nice to have

  • Medical device development with understanding of Design Controls (21 CFR 820.30)
  • 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
  • 21 CFR Part 4
  • 21 CFR 211
  • FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics
  • ISO 11040
  • ISO 10993

What the JD emphasized

  • Development experience in risk-oriented, regulated environments