Associate Director, Combination Product Development Lead

Responsibilities

• Lead development of combination product systems from late-stage development through commercialization
• Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF)
• Drive design verification and validation activities, including test strategy and execution
• Apply knowledge of injectable drug product characteristics to inform device design
• Lead risk management activities including hazard analysis and FMEA
• Manage and coordinate development activities across external vendors and partners
• Partner across Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing teams
• Own program-level tracking of timelines, risks, and deliverables using Smartsheet and Office Timeline

Requirements

• Bachelor’s degree in engineering or life sciences (advanced degree preferred)
• 8–12+ years of experience in combination product, drug–device, or medical device development
• Demonstrated experience owning a DHF/DDF through development and commercialization
• Hands-on experience with parenteral injectors
• Working knowledge of injectable drug product properties
• Experience managing external development and manufacturing partners in a regulated environment

About the Company

Vor is a biotechnology company focused on tackling autoimmune diseases at their root cause. By advancing telitacicept, a dual BAFF/APRIL inhibitor, Vor aims to redefine the future of autoimmune care and change the course of disease for patients worldwide.