Manager, operation
Core
Lead daily operations for a manufacturing line in Suzhou, ensuring safe, compliant, and efficient execution of cGMP/GRP production activities.
Role type
Senior IC manufacturing operations manager (cell manager)
Builds
Stable and scalable biopharmaceutical manufacturing operations
Domain
Biopharmaceuticals / Life Sciences / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GRP manufacturing operations, GMP compliance execution, deviation/CAPA management, audit readiness, frontline team leadership, performance management, cross-functional collaboration, Lean manufacturing, root cause analysis, daily management systems
Preferred skills
Cell culture media/bioprocessing experience, startup/process transfer/validation, SAP/MES/electronic batch records, Six Sigma/PPI certification
Technologies
SAP, MES, electronic batch records
Responsibilities
Lead day-to-day operations of the cGMP/GRP manufacturing cell, Ensure manufacturing activities are executed in compliance with GMP requirements, Lead and develop frontline manufacturing teams, Partner with Quality, Engineering, Supply Chain, and EHS to resolve operational issues, Support customer audits, regulatory inspections, and internal audits, Drive deviation follow-up, CAPA implementation, and root cause analysis
Seniority
Senior, hands-on IC