QC Manager招聘_喜康（武汉）生物医药有限公司最新招聘信息-猎才医药网

职位描述

职位描述： Job Responsibilities?Lead, coach and develop the Quality Control Laboratory team, review colleagues’ performance, and 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.?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.?Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.?Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness?Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews?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.?Proactively use scientific literature and guidelines to solve problems.?Ensure test methods are qualified/validated to support production of products for clinical or commercial use.?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.?May contribute to sections of regulatory submissions (primarily IND, BLA etc.).?Ability to recognize, trouble-shoot, and resolve problems with equipment or individual assays.Job Requirements:?Bachelor’s degree with 8+ years’ experience in Biotechnology industry in which 4+ years in quality managerial position, Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position.?Thorough knowledge of GMP regulations and documentation.?Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.?Ability to make contributions across departments, and to effectively interact across departments in pursuit of company goals.?Excellent verbal and written communication skills; able to communicate in English?Working knowledge of GMP as it relates to Biologics.?Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval 职能类别：生物工程/生物制药

公司信息

喜康生物由凯鹏华盈、红杉资本、柏乐创投、台湾中华开发工业银行率先出资建立。在喜康生物成立后的第二年，即2014年，台湾统一集团、富邦投资等台湾多家财团继续跟进投资完成B轮近3500万美元的融资。2015年3月，喜康生物完成C轮增资，本次募资金额达4560万美元，投资者包括管理资产额超过1.6万亿美元的全球知名的交叉基金麦顿投资、元生创投和利域投资管理公司。公司自成立以来，已成功募集超过1.35亿美元资金。2015年9月，喜康生物成功登录台湾资本市场。公司主营业务是为国际国内医药企业提供抗体药物研发及生产代工服务。成套引进国际抗体生产设备和质量管理体系，实现美国FDA和欧盟EMA标准认证。公司定位于治疗性抗体药物研发和产业化转化，为国际国内客户提供抗体工程细胞株筛选、培养基培养工艺优化、纯化制备工艺优化、工艺放大、质量研究和质量标准制定、临床前、临床研究样品制备及终端上市产品的生产、符合美国和欧盟的质量管理体系等内容的合同外包服务。喜康（武汉）生物医药有限公司的核心技术团队均来源于基因泰克（Genentech）、罗氏（Roche）以及辉瑞（Pfizer）等全球***生物医药领军企业服务背景，曾领导了多个重磅生物抗体药的研发与生产，尤其在抗体药大规模生产技术方面积累了领先于行业的宝贵经验。喜康生物目前在台湾新竹建设有符合国际标准的抗体药物研发及中式基地。2016年2月位于武汉光谷生物城的符合国际标准的模块化大分子生物制药工厂正式投入运营。喜康生物研发及生产的rituximab生物类似药（学名中译：利妥昔单抗）于2016年2月获得英国药监局核准，将在欧洲进行用于类风湿性关节炎病人之临床一期试验，成为一家获准在欧洲进行单克隆抗体生物类似药临床试验的生物制药公司。 2013年9月25日，美国通用电气（GE）正式在全球新闻发布，将为JHL公司在中国光谷生物城建设KUBio模块化生物制药工厂。KUBio不同于中国传统的生物制品厂的建设，它是一种建设生物制药工厂的全新方法，可在14-18个月内为客户提供功能齐全，可直接投入生产的生物制药工厂，相对于传统工厂，大大缩短了建设周期。KUBio 完全按照cGMP的验证要求设计，能帮助生物医药生产商迅速应对当地医疗需求，将能够挽救生命的药品推向市场。KUBio采用集成模块技术，其所有核心厂房的建设，装修，设备，均在德国建设完毕，然后运抵光谷生物城现场进行安装。 JHL的cGMP标准生产车间将通过美国及欧盟认证，生产工艺将达到国际领先水准，成为一家可以为全球生物制药合作伙伴提供完整解决方案的供应商。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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