Associate Director, Downstream Technical Operations Lead
Core
Lead end-to-end technical, manufacturing, and people accountability for complex biologics programs from technology transfer through commercial lifecycle management.
Role type
Senior IC downstream technical operations lead (biologics manufacturing)
Builds
Biologics drug substances via chromatography, filtration, and formulation unit operations
Domain
Biopharmaceutical manufacturing / Downstream processing
Required skills
Downstream process expertise (chromatography, filtration, formulation), GMP compliance, Technology transfer, PPQ execution, Deviation investigations, Root-cause analysis, Team leadership, Resource allocation, Process engineering, Single-Use Systems (SUS), Sterile manufacturing
Preferred skills
None stated
Technologies
Computerized Maintenance Management Systems (CMMS), Single-Use Systems (SUS)
Responsibilities
Maintain end-to-end technical ownership of assigned biologics programs; Provide visible floor-based technical support to resolve real-time manufacturing issues; Lead, coach, and develop a team of downstream scientists and engineers; Collaborate with cross-functional partners (Development, Quality, Engineering, Supply Chain) to drive strategic program delivery.
Seniority
Senior, hands-on IC with people leadership
