DP 4-生物制剂生产管理

1. Manufacturing Operations

• Deliver DP manufacturing services in full compliance with GMP, FDA, and EU regulatory requirements.
• Execute production plans on schedule, ensuring product quality, yield, and delivery commitments are consistently met.
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) throughout the manufacturing process. Identify and resolve production and operational issues; implement effective CAPA strategies to prevent recurrence.
• Be responsible for the identification, reporting, initiation, investigation, and closure of manufacturing-related deviations.
• Support audit readiness and responses by compiling documentation, analyzing observations, and implementing corrective actions.
• Collaborate cross-functionally to support validation activities (e.g., process validation, documentation, and training).
• Drive team engagement, operational efficiency, and strong team culture to enhance overall performance.

2. Project Management

• Serve as the primary interface with clients and internal project management teams for new project onboarding.
• Collaborate with Process Development, QA, and QC to ensure seamless tech transfer, including sampling strategy alignment and process coordination.
• Track project and tech transfer status, proactively identify risks and challenges, and communicate progress and mitigation plans to clients.
• Resolve issues encountered during project execution in coordination with project managers.
• Lead project implementation, ensuring client requirements and technical decisions are effectively communicated to and executed by the operations team.

3. New Facility / Line Setup

• Serve as the manufacturing representative for new construction and facility renovation projects, identify manufacturing and operational requirements in alignment with business needs, and ensure that facility design and equipment configuration support product processes, production capacity, regulatory compliance, EHS requirements, and future business growth.
• Develop manufacturing processes based on product characteristics; lead engineering alignment and equipment procurement (including vendor selection and bidding process).
• Coordinate cross-functional teams, including Manufacturing, Engineering, Automation, Validation, Quality, EHS, Supply Chain, and Project Management, to ensure that project requirements are aligned with future operational needs.
• Build and develop the operations team; support equipment qualification (IQ/OQ/PQ) and transition to routine manufacturing.

definition, equipment selection, design review, commissioning and qualification, validation, technology transfer, GMP manufacturing license readiness, and team building.

Key