苏州招聘

职位描述：
Requirements
? Doctoral degree with minimal 3 years, Masters’ degree with minimal 5 years of relevant industry experience with a major in Biochemistry, Bioengineering, Biochemical Engineering, Chemical Engineering or related fields
? At least 8 years of downstream process development experience
? Thorough working knowledge of GMP manufacturing
? Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD
? In-depth knowledge of scale-up principles, scale-down models, tech transfer concepts, and bioreactor characterization
? Must have working knowledge of applying DOE and statistical data analysis to development work. Familiarity with JMP or similar software is required
? Working knowledge of cell culture medium development, high-throughput cell culture technologies, advanced in situ analytics for process monitoring and control, and process modeling is highly desired.
? Understanding of validation of biopharmaceutical facilities, equipment and process
? Previous experience in successfully managing scientific and engineering functions.
? Proven skills in building and maintaining productive relationships with organizational partners such as manufacturing and quality
? Proven track record of continual innovation in various areas of the process development business
? Scientific eminence in the field of upstream process development demonstrated by consistent record of external presentations and publications
? Excellent communication and management skills

Responsibilities:
? Lead a technical team to develop cell culture and harvest process
? Lead upstream of CMC development scale up activities supporting GMP tech transfer and IND/NDA filings
? Provide leadership and management to a group of scientists and engineers. Ensure worker safety including training, supervision and control of safety guidelines.
? Identify, propose, and execute process and procedural changes to improve process performance, robustness, productivity and efficiency
? Collaborate within department and cross-functionally to meet set objectives
? Organize scientific presentations for internal discussion
? Contribute to preparation and submission of CMC portions of regulatory submissions 举报 分享

    苏州金盟生物技术有限公司成立于2010年9月。位于江苏省太仓市生物医药产业园，主要从事生物技术药物的研究、生产和销售。公司占地面积约60亩，建筑面积约3万平方米。
    2014年，上市公司深圳信立泰药业股份有限公司控股苏州金盟生物公司，为公司的快速发展注入了充足的血液。
    公司的核心团队具有25年的生物制品的开发和生产经验，能够进行基于大肠杆菌表达系统、酵母表达系统、动物细胞表达系统等一系列重组蛋白药物，以及基因治疗的开发研究及生产，团队被授予2010年度太仓市创新创领军人才、2011年度姑苏领军人才、2011年度江苏省“双创”人才，承担2013年江苏省科技成果转化专项资金项目。
    金盟生物为江苏省民营科技企业，建有苏州市重组蛋白药物工程技术研究中心，现有临床III期产品一项，临床II期产品项目1项，临床I期产品项目1项，SFDA临床审评中项目1项，以及若干储备项目，相关专利11项，授权专利9项。产品领域涉及：肿瘤、皮肤修复、眼科、消化系统疾病、自身免疫疾病、修复等领域，涵盖重组蛋白、重组抗体等。
公司现有四个产品，分别处于临床III、临床II和临床I期以及SFDA临床审评中。产品领域涉及：肿瘤、皮肤修复、自身免疫疾病等领域，涵盖重组蛋白、重组抗体等。
    公司在太仓生物医药产业园建设的生物医药生产基地，投资约3亿元，符合新版GMP的要求。生产基地共建有五条生产线，包括冻干粉针、西林瓶水针、卡氏瓶及年产2000万支冻干粉针原核生产线、2000L规模的一次性技术抗体生产线。
    金盟生物将基于现有技术优势和产业化基础，积极整合国内外优质生物技术资源，努力将金盟生物打造成为集生物医药研发、生产、销售于一体的现代生物技术公司。
公司网站：http://www.genemen.com