Lead the definition and execution of design verification strategies and design transfers for testing readiness, including incoming and release tests for components and combination products
Job Summary
Lead the definition and execution of design verification strategies and design transfers for testing readiness, including incoming and release tests for components and combination products.
Support critical activities such as drug product and combination product final assembly processes validations, requiring collaboration with cross-functional teams.
Author and review relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs.
Matching Summary
Lead the definition and execution of design verification strategies and design transfers for testing readiness, including incoming and release tests for components and combination products.
Salary
Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Design verification strategies
Combination product development
Test methodologies development
Regulatory submissions authoring
Cross-functional team collaboration
Nice-to-have
Analytical skills in product testing
Material characterization and failure analysis
3D CAD and rapid manufacturing
Collaboration and ideation skills
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 in design verification programs