长沙招聘

职位描述：
岗位职责:

1. 根据药品生产法规的要求，负责公司制剂工艺研究与工艺改进工作，对产品生产工艺流程、工艺标准、技术标准等文件的制定进行审核并能给予指导。
2.负责工厂新产品的研发和老产品的工艺改进，负责研发工艺至批量生产工艺的中试放大与生产，按新药研究要求，组织实施新药研发的立项、计划、试验、报批等工作，组织、编写、审核新药申报资料，不断开发出适合市场需求的新药品种。
1、According to the GMP requirements, responsible for formulation development. Audit and provide guidance on document making of the products manufacturing process procedure and technical standards.
2. Responsible for the R&D of new products and improvement of existing products formulation. In charge of implementation of the R&D technology, organize and implement new drug R&D project establishment, plan, experiment, submission etc.. Write and review new drug application document. Develop new drugs which meet the market demands.

任职资格:

1. 本科及以上学历，药学相关专业，药物制剂专业优先；海外工作背景者优先；
2. 具备15年以上制剂类规模企业的药品生产工作经验；熟练掌握制剂各种剂型工艺研究和工业化生产的流程以及各制剂新技术的实际生产应用，具备丰富的新产品技术转移和中试放大的工作经验；
3. 熟悉常用制剂生产所用设备的原理、性能，具有成功解决制剂生产工艺（特别是工艺放大生产和技术转移过程中）问题能力和经验；
4. 熟练掌握国内药品GMP及注册法规和技术指导原则的相关要求，熟悉欧美、ICH的产品研究、质量评价等指导原则要求；
5. 有较强的组织协调能力、分析和解决问题的能力。
6、优秀的英文听说读写能力。
1、BS degree or above in Pharmacy or related field, Pharmaceutical preparation is preferred. Work experience overseas is prioritized.
2、15+years drug production work experience in preparation company; familiar with the technologies of all kinds of preparation and the realistic use of new preparation technologies. Have rich experience in preparation technology transfer and pilot scale-up.
3、Familiar with theories and functions of the preparation production equipments; capable and have successful experience in problem-solving of preparation production process, especially in preparation technology transfer and pilot scale-up.
4、Familiar with GMP requirements and drug registration regulations, and the principles of ICH production research, quality evaluation in Europe and the US.
5、Be good at organization, cooperation, communication, problem-solving and team-leading.
6、Excellent skills in English listening, speaking, reading and writing.

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    先声药业是一家快速转型为创新和研发驱动的制药公司，获批建设 “转化医学与创新药物国家重点实验室”，致力于“让患者早日用上更有效药物”。先声药业专注于肿瘤（含细胞治疗）、中枢神经和自身免疫三大治疗领域，拥有多元化且领先的创新产品组合。秉持自主研发与合作研发双轮驱动的策略，先声药业与多家全球医药企业及生物技术公司成为战略合作伙伴，促进全球生命科学成果在中国的价值实现。