Assoc. Dir., Engineering
Core
Lead technology transfer of new large molecule products from R&D to commercial production in the US, ensuring robust processes and on-time launches.
Role type
Senior IC Associate Director (Process Development)
Builds
Robust manufacturing processes for antigens and final products
Domain
Biopharmaceuticals / Large Molecules
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing processes)
Required skills
Technology transfer, Process development, Project leadership, Risk mitigation (FMEA), Regulatory compliance (FDA/EMA/USDA), Team management, Data-driven decision making
Preferred skills
Commercial biomanufacturing (sterile/aseptic), Statistical process control, Design of Experiments (DOE), Strategic technology initiatives
Technologies
FMEA, DOE, CMC regulatory processes
Responsibilities
Develop robust processes for new products, manage technology transfer team, drive continuous process improvements, oversee risk identification and mitigation, manage strategic initiatives
Seniority
Senior, hands-on IC with management responsibilities
