QC经理 南通

月薪： 1-3万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 餐饮补贴
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 包住

职位描述

职位描述： 岗位说明：？1.Supervise the Company Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).？2.Responsible for antibody and protein drugs physical and chemical analysis, activity analysis and the analysis method of establishment and validation of impurities (including but not limited to HPLC, CE, limited detection, protein ultraviolet spectrum identification, determination of moisture and osmotic pressure, bacterial endotoxin detection, etc.);？3.Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, product, in-process, and raw material samples.？4.Lead, coach and develop the Quality Control Laboratory team, review colleagues’ performance, set and communicate objectives, priorities, metrics, development plans and conduct performance assessments.Lead and manage the laboratory testing for Analytical Chemistry, Biochemistry, Viral & Safety, Technical Services, and Senior Technical staff.？5.Align with corporate Quality processes and IT systems such as product testing, CAPA, lab investigations, stability testing, LIMS, lab equipment calibration providing support to QC Systems.？6.Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.？7.Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness？8.Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews？9.Manage performance and development of direct reports providing regularly scheduled feedback throughout the year to ensure achievement of organizational and department goals and a productive environment.？10.Proactively use scientific literature and guidelines to solve problems.？11.Ensure test methods are qualified/validated to support production of products for clinical or commercial use.？12.Identify and interact with outside manufacturers and contract test labs. Provide complete data analysis and be able to drive projects to completion using data generated in the design of new experiments and/or critical assessment.？13.May contribute to sections of regulatory submissions (primarily IND, BLA etc.).专业要求：？1.Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position. Medicine, biological analysis, analytical chemistry, biochemistry and other related professional;？2.Thorough knowledge of GMP regulations and documentation.？3.Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.？4.Excellent verbal and written communication skills; able to communicate in English？5.Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval学历要求：药学，生物类等相关专业本科以上学历1.主要负责建立抗体及蛋白质产品的物理化学分析、生化活性分析，杂质分析的分析方法开发以及方法学确认。主要分析方法包括：HPLC、CE、有限检测、蛋白质紫外光谱识别、测定水分和渗透压、细菌内毒素检测等2.负责监督环境监测项目，包括系统确认、设施确认、周期性监测(抽样、测试、趋势分析等);3.负责为质量控制部门的环境监测，产成品、中控样品以及原辅料的检测和评价提供技术支持。4.负责确保质量控制部的流程符合要求，为QC的系统管理(如产品测试、CAPA、实验室OOS调查、稳定性测试、LIMS系统、实验室设备校准等)提供支持5.确保实验室的文档管理和实验室流程管理处于持续的符合法规要求。6.确保测试方法的有效性，以支持产品的临床或商业使用。7.负责第三方合作单位或者第三方实验室的审计，并对新实验室进行评估，确保数据的完整性。8.协助公司向法规部门（IND, BLA等）提交产品注册资料。 职能类别： 生物工程/生物制药 质量管理/测试经理(QA/QC经理)

联系方式

海门生物科技创业园

公司信息

澳斯康生物制药（海门）有限公司注册资本1000万，由美籍华人罗顺博士（中组部第六批创业“千人计划”成员）于2017年3月在江苏省南通市海门生物医药科创园创立。澳斯康作为新兴的CRO/CMO企业，旨在为中国生物制药研发提供端到端的产业化服务，包括工艺检测技术开发及验证、工艺放大、稳定性考察、临床前到临床阶段的样品cGMP标准制备、及cGMP商业化规模的产品生产。澳斯康拥有国内外顶尖专家和顾问团队，他们中的很多都在基因泰克、安进、默克等国际知名企业有着研发和高管经历，在生物制药工艺及产业化方面拥有多年的经验。澳斯康可以提供世界最先进水平的CRO的研究及工艺技术开发服务，其CMO商业化生产标准可同时满足中国CFDA、美国FDA、及欧盟EMEA标准。 澳斯康致力于打造中国生物制药行业集原材料供应、技术服务、合同生产于一体的行业领头企业，专注于生产工艺技术开发服务（CRO）、中试及商业化规模合同生产服务（CMO）、以及关键生产原材料（细胞培养基）供应。拥有生物制药行业顶尖团队，可为客户提供“研发->生产->物流->技术支持->售后”的一站式服务，包括细胞株开发、培养基优化、细胞培养工艺开发、纯化工艺开发、制剂工艺开发、检测分析方法建立优化、检测外包服务、中试非GMP及GMP级别生产用于临床前及临床研究样品、协助注册申报、全产业链技术咨询等个性化定制服务。专注整体生物制药生产成本控制，力争达到每克蛋白药物平均生产成本在五十美金以下，真正让老百姓都能用得起安全、高效、质量一致可控的生物药品。 免费住宿、五险一金、探亲补贴、油补、饭补、话费补贴、各种不定期团建活动…… 天高任鸟飞，海阔凭鱼跃。我们为你创造广阔的发展空间，澳斯康期待你的加入！

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