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Open nowPosted 276 days ago

CMC 制剂总监

evopointbio/73901724 open roles

Where
Suzhou, Jiangsu, Chinese Mainland
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Your applicationOpen nowCMC 制剂总监evopointbio/739017 · Suzhou, Jiangsu, Chinese Mainland

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The clock on this job

Early applications get read.

11.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: posted 276 days ago

The posting

1.参与制剂项目的立项及调研分析，为立项提供技术指导支持。 2.配合CMC项目管理部门制定各项目的制剂年度预算和年度生产计划。 3.设计/优化制剂处方工艺，指导进行处方工艺的开发和优化工作。 4.负责生产工艺转移，协助受托生产商进行中试放大生产并解决中试放大过程中遇到的问题，保证及时供应临床研究试验用药和毒理制剂样品。 5.负责制剂项目的计划方案的制定、实施、协调、汇报及总结等，保证项目的研发进度。 6.负责管理供应商或内部进行制剂商业化生产的处方工艺设计，工艺优化及QRA研究工作。 7.负责监管供应商完成申报上市所需的工艺预验证，验证工作，清洁验证动态核查等相关工作。 8.负责撰写项目制剂相关的专利。 9.供应商管理工作（包括CXO公司、第三方检测单位、仓储单位等） 10.与药监部门沟通及制剂相关资料整理和撰写

1、至少具有药物制剂、药学或相关专业硕士以上学历（或中级专业技术职称或执业药师资格）。 2、具有至少七年从事药品生产管理或药物研发的实践经验，其中至少五年的药物研发经验，接受过与所研发产品相关的专业知识培训。 3、熟悉处方工艺开发的基本知识，熟悉生产设备和工艺流程，具有GMP中试放大生产经验。 4、熟悉商业化项目的工艺开发，QbD研究，工艺验证，清洁验证等流程。 5、熟悉化学药品注册法规和指导原则的技术要求，熟悉申报资料的撰写和整理工作，能够独立编写注册申报资料。

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