Manager Manufacturing Programs – Process Owner Team
Core
Lead a team of Process Owners to ensure manufacturing processes are effectively translated into operational execution, procedures, and digital workflows for GMP drug substance manufacturing.
Role type
Manager, Manufacturing Programs (Process Owner Team)
Builds
GMP-compliant drug substance manufacturing operations
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing operations, process stewardship, operational readiness, CAPA implementation, change control management, manufacturing execution systems (MES), electronic batch records (EBR), single-use technologies, Bill of Material (BOM) structures, cross-functional partnership
Preferred skills
Upstream & Services or Downstream manufacturing expertise, facility fit assessments, process implementation, knowledge transfer, risk assessments, root cause analysis
Technologies
Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), single-use technologies
Responsibilities
Lead, coach, and manage a team of Process Owners; Provide leadership for technical process stewardship and process governance; Oversee operational readiness activities including water runs, dry runs, and equipment verification; Drive closure of commitments associated with CAPAs, risk assessments, and change controls; Ensure translation of manufacturing processes into SOPs and digital workflows; Support inspection readiness and represent the organization during audits.
Seniority
Manager, people leadership