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5-7年经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： We are inviting a hands-on and result-driven formulation development and GMP manufacturing scientist or manager to join our team in supporting the growing need of formulation process scale-up, technical transfer and GMP manufacturing for solid oral dosage forms.Responsibilities:Develop formulation process scale-up and technical transfer (TT) documents working with formulation development scientists from lab to CMOs or between different manufacturing sites. Prepare process optimization study, TT strategy, plan and protocol. Oversee and execute batch manufacturing and data analysis, and prepare TT report and process study report. Solve potential formulation and manufacturing technical issues.Work with formulation development scientists together to produce investigational drug products for clinical trial from early stage to late stage. Coordinate with CMOs to prepare manufacturing timeline, contracts and BMRs to make sure clinical supply timely.Collaborate with other functional groups in pharmaceutical development, manufacturing plant, regulatory affairs, and clinical supply operation to push project forward smoothly from IND to NDA.Qualifications:PhD or Master or Bachelor in Pharmaceutical related Sciences or Engineering. Bachelor with 8+ years, Master with 5+ years, or PhD with 3+ years of experience in pharmaceutical industry, with hands-on experience of formulation development, TT and/or manufacturing technical service, especially in oral solid dosage forms.Working experience in international pharmaceutical companies is preferred.Solid understanding of cGMP knowledge and CFDA/FDA/ICH guidelines is a must.Hands-on clinical supply experience or supply chain management is a plus.Good in writing and speaking both Chinese and English. 职能类别： 医药技术研发人员
联系方式
上海市浦东新区张江高科技园区蔡伦路720弄4号楼
公司信息
和记黄埔医药（上海）有限公司(和记黄埔医药)是一家由香港和记黄埔有限公司（和黄）全资投资的医药研发企业。和黄成立于十九世纪，是香港著名的跨国公司，现已成为全球500强企业之一。 和记黄埔医药2002年9月成立，位于上海张江高科技园区，公司致力于为全球市场开发创新药物。和记黄埔医药拥有一套完整的药物研发体系和一流的研发平台。公司的高级管理层主要来自美国的世界知名医药及生物科技公司，拥有丰富的新药研发管理经验。在短短几年中，公司在癌症和自身免疫性疾病领域，开发了多个临床前和进入临床研究阶段的创新药物。公司现有两个创新药物在美国、欧洲和澳大利亚进行临床实验，同时还有多个项目正在中国处于临床前及临床开发阶段。 和记黄埔医药通过将世界一流的研发经验、技术平台与中国的资源相结合， 开发出高质量的临床候选药物，并将新药项目快速推入早期临床开发。和记黄埔医药通过多种研发途径来达到最优的产出，包括来自合成小分子化合物、半合成天然产物以及植物药的创新药物。成立至今，和记黄埔医药已与世界知名医药公司在多种疾病领域内建立了广泛的战略合作。 和记黄埔医药为员工提供有竞争力的薪资福利、以人为本的工作环境和良好的职业发展机会。我们期待敢于挑战的优秀人才加入我们的团队。
