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About the role
Key responsibilities & impact- Provides end-to-end leadership and oversight for commercial manufacturing and supply execution through external manufacturing partners, ensuring reliable supply, compliant operations, and sustained process performance across product lifecycle stages.
- Accountable for production strategy, production supply planning, manufacturing readiness, startup of external manufacturing operations in China, technology transfer, process validation support.
- Conducts on-site monitoring at CMO/CDMO partners, oversight of in-process testing and release testing in partnership with Quality Operations, deviation and change management, and continuous improvement across drug substance, drug product, and finished goods operations.
- Acts as the senior production representative for external manufacturing operations, leading cross-functional decision-making, risk management, escalation management, and cross-functional PO&T projects with internal and external stakeholders.
Requirements
What you’ll need- Bachelor’s degree in pharmaceutical sciences, chemical engineering, bioprocess engineering, biotechnology, or related scientific discipline; advanced degree preferred.
- Typically 10+ years of relevant pharmaceutical or biotechnology industry experience in manufacturing, process sciences, technical operations, or external manufacturing, including significant experience in biologics and/or sterile products.
- Demonstrated leadership experience in complex, regulated manufacturing environments, including oversight of external partners, cross-functional teams, inspections/audits, and regulatory or quality-critical decision-making.
- Professional proficiency in English and Chinese (written and spoken) required to effectively manage collaboration.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Manufacturing ReadinessSupply PlanningTechnology TransferIn-Process TestingChange ManagementContinuous ImprovementBiologics ManufacturingSterile Products ManufacturingQuality OperationsDeviation Management
Soft Skills
LeadershipCollaborationDecision-MakingRisk ManagementCommunication
