DP 4-生物制剂生产管理

负责生物制剂灌装生产管理，包括但不限于灌装线、配液准备、灯检/包装生产活动管理，管理团队日常生产，负责对接客户、完成项目管理，同时负责新厂建设，作为DP代表参与厂房工艺布局、用户需求定义、设备选型、设计审核、调试确认、验证、技术转移及GMP生产许可准备和团队建设：

生产管理：

1.为客户提供符合GMP、FDA、EU要求的制剂生产服务；

2.根据部门生产计划，按时保质保量的完成客户的生产；

3.监督生产过程中的关键工艺参数和关键质量属性，针对项目生产和车间日常运营产生的问题，能给出合理有效的解决方案，并有相关手段避免以后重复发生；

4.负责生产相关偏差的识别、报告、启动、调查和关闭；

5.针对各类审计缺陷，收集整理和归纳相关材料，并制定相应的解决方案；

6.配合同级完成验证、文件、培训等验证工作和完成上级下达的其他工作任务；

7.提高团队工作积极性和工作效能，增强团队凝聚力；

项目管理：

1.与客户、项目管理有效沟通引入新的项目。

2.与工艺研发，质量保证，质量控制等部门有效沟通确保项目的工艺转移工作，确认相关取样方案，协调生产工艺。

3.掌握工艺转移及项目的状态，工艺转移中的挑战和进展及后续计划，并向客户汇报。

4.协调处理项目经理在项目执行过程中出现的各种问题。

5.领导项目实施，确保客户及工艺转移讨论过程中的要求被有效传递到运营团队。

新厂建设：

1.作为生产部门代表参加新建或改造项目，负责提出生产运营需求，确保厂房设计及设备配置满足产品工艺、产能、法规、EHS及未来业务发展要求根据业务需求。

2.基于产品特性设计生产工艺，完成工程对接和设备招投标。

3.协调生产、工程、自动化、验证、质量、EHS、供应链和项目管理团队，确保建设需求与未来实际运营需求保持一致。

4.建设团队，对接设备验证及后续生产。

Responsible for end-to-end management of biologics drug product (DP) manufacturing, including aseptic filling, compounding, visual inspection, and packaging operations. This role oversees daily production activities, client interface, and project management, while also leading new facility setup, serving as the manufacturing representative in facility and process layout design, user requirement definition, equipment selection, design review, commissioning and qualification, validation, technology transfer, GMP manufacturing license readiness, and team building.

Key Responsibilities

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.