Specialist Manufacturing – Process Owner - Upstream / Downstream / Services
Core
Technical process steward responsible for manufacturing execution, floor support, operational readiness, and continuous improvement in drug substance manufacturing.
Role type
Specialist Manufacturing Process Owner (Upstream/Downstream/Services)
Builds
Drug substance manufacturing operations at Amgen's FleX Batch facility
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, process governance, troubleshooting, root cause analysis, CAPA implementation, SOP authoring, risk assessment, MES/EBR support, change control management
Preferred skills
Upstream/Downstream manufacturing expertise, single-use technologies, Bill of Material alignment, water/dry run execution, equipment readiness verification
Technologies
MES, EBR, single-use assemblies
Responsibilities
Serve as technical process owner for assigned unit operations; provide floor support and troubleshooting during routine operations and startup; support operational readiness activities; monitor process performance and drive optimization; author and maintain GMP documentation; participate in risk assessments and investigations; support change controls and CAPA activities.
Seniority
Specialist, hands-on IC
