Senior Manager Process Engineering - Bulk Drug Substance - Downstream
Core
Oversee engineering teams and lead technical projects for downstream purification and plant equipment in biopharmaceutical drug substance manufacturing.
Role type
Senior Manager, Process Engineering (Downstream)
Builds
Biologics drug substance production systems (Chromatography, viral Filtration, UFDF, CIP/SIP skids)
Domain
Biopharmaceutical manufacturing / Downstream processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering, plant equipment management, commissioning and qualification, GMP compliance, team leadership, project management, equipment maintenance planning, risk management, budgeting
Preferred skills
Chemical or Mechanical Engineering degree, biopharmaceutical operations experience, tech transfer, process design, regulatory agency interaction, analytical problem solving
Technologies
Chromatography systems, viral filtration skids, UFDF, CIP/SIP skids
Responsibilities
Execute commissioning and qualification of process equipment per GMP; lead a team of process engineering professionals; provide system ownership for downstream purification and CIP/SIP skids; implement engineering-based improvements and upgrades; ensure 24/7 operational reliability and regulatory compliance; manage budgeting and resource allocation for process engineering
Seniority
Senior, hands-on IC with management responsibilities
