Associate Director (Engineering), Biologics External Manufacturing Technical Operations
Core
Lead technical operations for biologics external manufacturing partners, ensuring compliance, supply continuity, and cost reduction while managing technology transfers and process optimization.
Role type
Senior IC Associate Director (Engineering, Biologics External Manufacturing)
Builds
External manufacturing partnerships and technology transfer programs for vaccines and biologics
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Biologics manufacturing, Technology transfer, Process sciences, Lean Manufacturing, Regulatory compliance, Capital project management, Problem-solving, Team leadership, Change management, Matrix management
Preferred skills
Large molecule unit operation design, Cross-functional team leadership, International environment experience, Process troubleshooting
Technologies
Automation Systems, Manufacturing Scale-Up
Responsibilities
Provide technical oversight and planning for complex external partner models; Execute technical due diligence and validate partner capabilities; Lead technology transfer delivery and site readiness; Develop validation strategies and monitor process performance; Resolve production issues and guide process optimization; Manage partner risk assessment and mitigation plans.
Seniority
Senior, hands-on IC with leadership responsibilities