Associate Director, Engineering
Core
Lead technical transfers and commercial supply for biologics external manufacturing partners, ensuring compliance, supply continuity, and cost reduction for vaccines and biologics.
Role type
Senior IC manufacturing engineering leader (biologics external manufacturing)
Builds
Commercial supply chains and technical transfer programs for biologics
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Biologics manufacturing, Technical transfer leadership, Cross-functional team leadership, Process sciences, Analytics, Lean Manufacturing, Regulatory compliance, Root cause analysis, Manufacturing scale-up, Capital project management
Preferred skills
Large molecule unit operation design, International matrix organization experience, Change management, Automation systems
Technologies
None explicitly listed
Responsibilities
Provide single point of technical contact for external partners; Execute technical transfers and receiving site readiness; Lead risk assessment and mitigation for partners; Develop and execute validation strategies; Provide process support and optimization guidance; Coordinate complex investigations; Review process change requests and deviations; Ensure inspection readiness for new product introductions.
Seniority
Senior, hands-on IC with significant leadership