Manager, operation

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Location: Suzhou, China
Job Type: Full-time
Function: Manufacturing Operations / CMC

Position Summary

We are seeking an experienced Cell Manager to lead daily operations for a manufacturing line in Suzhou. This role is responsible for ensuring safe, compliant, and efficient execution of manufacturing activities, while driving operational excellence across production, people management, quality, safety, and continuous improvement.

The Cell Manager will lead frontline manufacturing teams, support audit readiness, partner closely with Quality, Engineering, Supply Chain, and EHS, and play a key role in establishing stable and scalable operations for both GRP and cGMP-related production activities.

Key Responsibilities

• Lead day-to-day operations of the cGMP / GRP manufacturing cell, including production execution, resource coordination, scheduling, and issue escalation.
• Ensure manufacturing activities are executed in compliance with GMP requirements, site procedures, quality systems, and EHS standards.
• Build and maintain a strong culture of safety, quality, compliance, accountability, and continuous improvement on the shop floor.
• Lead and develop frontline manufacturing teams, including performance management, coaching, training, qualification tracking, and workforce capability building.
• Ensure production records, batch documentation, line clearance, and shop floor practices meet required quality and compliance standards.
• Partner with Quality, QC, Engineering, Supply Chain, Warehouse, and EHS to resolve operational issues and ensure uninterrupted production support.
• Support customer audits, regulatory inspections, and internal audits by maintaining a high level of inspection readiness.
• Drive deviation follow-up, CAPA implementation, root cause analysis, and corrective action execution in collaboration with cross-functional teams.
• Support process transfer, startup, validation, scale-up, and operational readiness activities as needed.
• Lead Lean manufacturing and operational excellence initiatives to improve safety, quality, delivery, cost, and productivity.
• Establish and sustain daily management systems, visual management, standard work, and other shop floor management practices.

Minimum Qualifications

• Bachelor’s degree or above in Biotechnology, Bioprocessing, Pharmaceutical Science, Life Sciences, or a related field.
• Minimum 8 years of relevant work experience in pharmaceutical, biopharmaceutical, life sciences, or other regulated manufacturing environments.
• Minimum 3 years of production management experience leading frontline manufacturing teams.
• Hands-on pharma GMP-related experience is required, including experience in GMP manufacturing operations, GMP documentation, deviation/CAPA management, audit readiness, and compliance execution.
• Proven experience in managing day-to-day shop floor operations in a manufacturing environment.
• Strong people management experience, including coaching, performance management, and team development.
• Experience working cross-functionally with Quality, Engineering, Supply Chain, EHS, and other support functions.
• Experience driving operational discipline and daily management systems in a production environment.
• Demonstrated experience in Lean manufacturing, continuous improvement, or operational excellence programs.
• Good English communication skills, both written and verbal.

Preferred Qualifications

• Experience in cell culture media, bioprocessing, biologics, buffers, reagents, or related manufacturing operations.
• Experience in startup, process transfer, validation, or ramp-up of new manufacturing capabilities.
• Familiarity with SAP, MES, electronic batch records, or manufacturing planning systems.
• Experience supporting customer audits and regulatory inspections.
• Formal training or certification in Lean, Six Sigma, PPI, or related continuous improvement methodologies.

Key Skills and Competencies

• Strong shop floor leadership
• GMP compliance mindset
• People leadership and team development
• Audit readiness and inspection support
• Structured problem solving and root cause analysis
• Cross-functional collaboration
• Lean manufacturing and continuous improvement
• Strong communication and execution discipline
• Ability to manage priorities in a dynamic manufacturing environment