Job Summary

• Lead the definition and execution of design verification strategies, and design transfers for testing readiness, which includes incoming and release tests for components and combination products.
• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.
• The salary range for this role is $142,400.00 - $224,100.00.

Matching Summary

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: annual bonus and long-term incentive, if applicable; Benefits: 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

Skills & Requirements

Key Requirements

• B.S. + 8 years combination product development
• M.S. + 5 years combination product development
• Ph.D. + 3 years combination product development
• Leadership experience combination product design verification
• Knowledge of device development interdependencies
• Understanding of drug product development
• Familiarity with regulatory landscape

Work Rights