主要职责：负责生物药品的全生命周期中制剂相关工作，涵盖前期申报、早期临床、关键临床及上市后阶段。通过处方及制剂生产工艺开发、中试批制剂生产、制剂生产工艺放大与转移、商业化生产支持等核心工作，确保生物制剂的研发和生产顺利开展，以推动项目顺利推进及申报。Responsible for formulation-related activities throughout the full lifecycle of biologics, spanning pre-IND application, early clinical phases, pivotal clinical phases, and post-marketing stages. Core responsibilities include formulation development, pilot-scale batch production, process scale-up and technology transfer, and commercial manufacturing support, ensuring seamless execution of biologics R&D and production to drive project advancement and regulatory submissions.

一、研发与申报阶段R&D & Regulatory Submissions

1. 1、完成处方筛选、临床制剂生产工艺开发、中试生产，设计非临床/临床样品使用中稳定性研究方案，撰写制剂部分申报资料；Conduct formulation screening, clinical formulation process development, and pilot-scale production; design stability study protocols for non-clinical/clinical in-use samples; author formulation-related sections of regulatory submission documents.

1. 2、开展制剂工艺表征、工艺验证方案设计，完成关键临床阶段及商业化制剂稳定性对比研究，参与说明书制剂相关参数制定。Perform process characterization, design process validation protocols, complete stability comparability studies for pivotal clinical and commercial formulations, and participate in defining formulation-related parameters for product labeling.

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二、技术转移与生产支持Technology Transfer & Manufacturing Support

1. 1、完成进口辅料/包材的国产化质量对比研究，制定可替代性评估报告；Conduct localization quality comparability studies for imported excipients/packaging materials, and draft alternate source qualification reports.

1. 2、完成从研发到GMP生产的制剂工艺技术转移，解决首批放大生产中的异常问题，建立生产监控SOP。Lead formulation technology transfer from R&D to GMP manufacturing, resolve deviations during first GMP production batches, and establish production monitoring SOPs.

三、上市后全周期管理

1. 1、审核生产批记录，主导冻干曲线优化、灌装精度偏差等异常情况调查，开展补充性稳定性研究；Review batch records, lead investigations into deviations (e.g., lyophilization cycle optimization, filling accuracy deviations), and conduct supplementary stability studies.

1. 2、执行辅料供应商变更、生产场地变更等支持性研究，撰写变更申报资料；Execute supportive studies for changes (e.g., excipient supplier change, manufacturing site transfer), and draft change control submission documents.

1. 3、分析客户投诉中的制剂相关问题，提供技术解决方案及内部培训。Analyze formulation-related customer complaints, provide technical solutions, and deliver internal training.