Associate Director Drug Product Technical Operations
Core
Lead technical and operational execution of drug product activities across an external manufacturing network from late-stage development through commercialization.
Role type
Associate Director, Drug Product Technical Operations
Builds
Biologic drug products for autoimmune diseases (telitacicept)
Domain
Biopharmaceuticals / Autoimmune Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologic drug product development, aseptic fill-finish, process validation, CDMO management, Module 3 authoring, lifecycle management, deviation investigation, technology transfer
Preferred skills
Advanced degree in engineering/pharmaceutical sciences, experience in commercial manufacturing
Technologies
Smartsheet, Office Timeline
Responsibilities
Lead planning and execution of engineering, clinical, validation, and commercial manufacturing campaigns; Define and execute Drug Product CMC strategy; Lead process validation strategies and commercial readiness; Manage technology transfers and post-approval changes; Author and review Drug Product Module 3 content; Support health authority meetings and inspections; Serve as primary technical interface with external CDMOs; Lead deviation investigations and CAPAs; Partner on combination product integration; Manage program timelines and technical risks.
Seniority
Senior, hands-on IC
