Senior Manager – Manufacturing Programs - Process Owner Organization
Core
Lead the Process Owner organization to provide technical process stewardship, manufacturing support, and governance for Upstream, Downstream, and Services Drug Substance Unit Operations at a new advanced drug substance manufacturing plant.
Role type
Senior Manager, Manufacturing Programs (Process Owner)
Builds
Drug substance manufacturing operations using single-use and stainless steel technologies with embedded Industry 4.0 capabilities.
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical process stewardship, manufacturing change control, GMP compliance, team leadership, operational readiness planning, electronic batch record (EBR) implementation, manufacturing execution system (MES) integration, Bill of Materials (BOM) management, CAPA management, audit support.
Preferred skills
8+ years in biotech/pharma manufacturing, managing technical teams, GMP documentation governance (Veeva/Documentum), digital manufacturing systems, supply chain partnership, process reliability improvement.
Technologies
Veeva, Documentum, MES, Industry 4.0 platforms
Responsibilities
Lead and develop the Process Owner organization; provide direct management and career development for Process Owners; establish and lead a swing-shift Process Owner team; oversee execution of dry runs, water runs, and engineering runs; serve as primary interface between Manufacturing Operations and support functions (Quality, Engineering, C&Q, Supply Chain); own manufacturing-related CAPAs and change controls; support inspection readiness and regulatory audits.
Seniority
Senior, hands-on IC with management responsibilities
