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主要職責(zé)：負(fù)責(zé)生物藥品的全生命周期中制劑相關(guān)工作，涵蓋前期申報、早期臨床、關(guān)鍵臨床及上市后階段。通過處方及制劑生產(chǎn)工藝開發(fā)、中試批制劑生產(chǎn)、制劑生產(chǎn)工藝放大與轉(zhuǎn)移、商業(yè)化生產(chǎn)支持等核心工作，確保生物制劑的研發(fā)和生產(chǎn)順利開展，以推動項目順利推進(jìn)及申報。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、研發(fā)與申報階段R&D & Regulatory Submissions
1. 1、完成處方篩選、臨床制劑生產(chǎn)工藝開發(fā)、中試生產(chǎn)，設(shè)計非臨床/臨床樣品使用中穩(wěn)定性研究方案，撰寫制劑部分申報資料；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、開展制劑工藝表征、工藝驗證方案設(shè)計，完成關(guān)鍵臨床階段及商業(yè)化制劑穩(wěn)定性對比研究，參與說明書制劑相關(guān)參數(shù)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、技術(shù)轉(zhuǎn)移與生產(chǎn)支持Technology Transfer & Manufacturing Support
1. 1、完成進(jìn)口輔料/包材的國產(chǎn)化質(zhì)量對比研究，制定可替代性評估報告；Conduct localization quality comparability studies for imported excipients/packaging materials, and draft alternate source qualification reports.
1. 2、完成從研發(fā)到GMP生產(chǎn)的制劑工藝技術(shù)轉(zhuǎn)移，解決首批放大生產(chǎn)中的異常問題，建立生產(chǎn)監(jiān)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、審核生產(chǎn)批記錄，主導(dǎo)凍干曲線優(yōu)化、灌裝精度偏差等異常情況調(diào)查，開展補(bǔ)充性穩(wěn)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、執(zhí)行輔料供應(yīng)商變更、生產(chǎn)場地變更等支持性研究，撰寫變更申報資料；Execute supportive studies for changes (e.g., excipient supplier change, manufacturing site transfer), and draft change control submission documents.
1. 3、分析客戶投訴中的制劑相關(guān)問題，提供技術(shù)解決方案及內(nèi)部培訓(xùn)。Analyze formulation-related customer complaints, provide technical solutions, and deliver internal training.