Director, Manufacturing Operations
Core
Direct execution of clinical and commercial manufacturing processes for therapeutic proteins (biologics) in accordance with cGMPs.
Role type
Director, Manufacturing Operations (Biologics)
Builds
Therapeutic proteins (e.g., Orencia, Empliciti, Opdualag) and clinical pipeline biologics
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, upstream/downstream operations management, finite scheduling, team leadership (>30 people), process efficiency optimization, regulatory audit readiness, change management, budget management
Preferred skills
Engineering principles, manufacturing automation systems, technology transfer, process development
Technologies
Manufacturing automation systems
Responsibilities
Direct Upstream/Downstream operations, allocate resources to meet production targets, manage New Product Introductions, drive safety leadership and CAPA closure, maintain audit readiness, identify process bottlenecks, coordinate cross-functional resources (QA/QC, Engineering, Supply Chain), coach and develop high-performing teams, manage critical stakeholder interfaces
Seniority
Director, strategic leadership & operational execution
