Associate Principal Scientist – Combination Product Design Verification

About the role

We are looking for an experienced scientist to lead the design verification strategy for drug‑device combination products. The role will drive end‑to‑end testing activities, from method development to clinical and commercial release, within our Device Development & Technology team.

Key responsibilities

• Define design inputs/outputs and lead the creation of verification plans, protocols and reports.
• Develop and validate test methodologies, including accelerated and real‑time aging studies.
• Oversee verification activities performed by external partners and ensure testing readiness for stability, filling, assembly and shipping studies.
• Author and review regulatory submission sections (IND, IMPD, NDA, BLA) for combination product programs.
• Coordinate cross‑functional teams and suppliers to align testing strategies with development, manufacturing and quality goals.

Required profile

• B.S./M.S./Ph.D. in Mechanical Engineering (or equivalent) with 3‑8 years of combination product development experience.
• Proven leadership of design verification programs and experience with device design controls, risk management and process validation.
• Strong understanding of drug product development and related regulatory landscape.

Required skills

• Design verification and validation
• Test method development and validation
• Analytical transfer and method qualification
• ISO 11608, ISO 11040, ISO 80369 standards
• Risk management and design controls
• Regulatory submission authoring (IND, IMPD, NDA, BLA)