- 无工作经验
- 本科
- 招若干人
- 11-09 发布
职位描述
职位描述: Job Description:The upstream manufacturing manager position is available in Biologics Manufacturing Department at ChemPartner in Shanghai. As the manager of upstream manufacturing, you will report to Sr. Director, Head of Biologics Manufacturing. In this position, you will provide tactical leadership to the upstream manufacturing group and be responsible for upstream cell culture manufacturing performed in compliance with current good manufacturing practices (cGMP) required by CFDA, US FDA and EMA. You will collaborate with downstream manufacturing group, fill/finishing group, process development and other supporting departments to ensure upstream production goals are achieved according to project schedule.Qualifications:The ideal candidate will have a BS/MS degree in Biochemical Engineering, Chemical Engineering, Biochemistry or related field from an accredited college or university and a minimum of 5 years working experience in a cGMP environment. Extensive working knowledge in cell culture at pilot and/or commercial scale is required. Management experience with years of progressive experience in biologics manufacturing is a plus. The successful candidate must be a goal-oriented team player with excellent communication skills and adaptive to a quality and time-line driven work environment.The ideal candidate will also have demonstrated knowledge and qualification in:?Working knowledge of Current Good Manufacturing Practices (cGMP).?Technical knowledge of cell culture manufacturing processes, equipments, procedures and systems.?Previous experiences in cell culture scale-up, technology transfer including drafting production batch records, technology transfer and process qualification protocols etc., are highly desired?Hands-on experience in equipment, process qualifications and regulatory requirements.?Responsible for scheduling and coordinating the upstream manufacturing work to meet project timeline.?Familiar with deviation investigation, CAPA implementation and cGMP quality system.?Functioning as a team leader, coach, mentor, and managing direct reports.?Directing, supervising, coordinating, delegating and reviewing the work of assigned department personnel.?Excellent communication, organization and collaborative skills are essential. Ability to read, write and speak in English is required. 职能类别: 临床研究员 生物工程/生物制药
联系方式
上海市浦东张江高科技园区哈雷路998号
公司信息
ShangPharma, the holding company of Shanghai ChemPartner Co. Ltd. and Shanghai ChemExplorer Co. Ltd., is one of the largest CROs (Contract Research Organizations) in China and provides a comprehensive portfolio of services to global pharmaceutical and biotech companies. We have a team of skilled scientists and a problem-solving culture that enable us to respond to our clients' toughest challenges. Headquartered in Zhangjiang Hi-Tech Park, Pudong New Area of Shanghai, ShangPharma currently has a staff of more than 1,600 scientists in virtually every discipline. Over 40% of our scientific staff have post-graduate degrees and all of our top scientific leaders have U.S. and/or European industrial experience in major international pharmaceutical and biotechnology companies. ShangPharma---- Meeting Your Demands With a commitment to meeting your demands, ShangPharma offers unparalleled expertise, experience, and results. ShangPharma understands the rapidly changing challenges which face pharmaceutical and biotechnology companies of all sizes in developing innovative drugs. Our CRO business is built around your demands, our integrated services are designed to help bring your new products to market as safely, efficiently, and cost-effectively as possible. 尚华医药研发服务集团(SHP)旗下拥有上海睿智,上海开拓者,上海凯惠和成都凯惠四家子公司。2007年10月,TPG向尚华医药投资逾3000万美元。公司目前主要从事为国内外客户提供组合化学、药物化学、合成化学等领域的科研服务;化工医药产品质量测试;医药生物技术引进、孵化以及成果产业化等业务。2010年10月19日尚华医药登陆纽交所。 睿智化学 2003 年 4 月成立于中国药谷——上海张江高科技园区生物医药基地内,目前已拥有 13000 平方米的具备先进科研设备的国际领先标准的化学实验室。公司汇集了超过 600 人的来自海内外的精英队伍。公司的科研管理团队均由具十几年海外工作经验的博士组成,研究人员均在大型企业集团及科研院所从事多年研究与开发的高级人才,具有丰富的科研经验和创新意识。睿智化学以其先进的技术优势、具有竞争力的人才优势、以及完善的客户服务管理已经和众多 全球排名前 20 位的生物及制药企业展开 多层次的富有成效的 科研合作,成果斐然。 开拓者化学 2002 年 6 月成立于中国药谷——上海张江高科技园区生物医药基地内,通过与世界 500 强公司之一的美国礼来公司签署长期合作协议,双方共同在张江建立了礼来在中国最大的协作研究基地——开拓者化学。这种创新的合作模式为公司积累了丰富的研究经验,培养了高素质的科研队伍和高效率的科研平台。使公司在短时间内达到实验室面积 13000 多平米,研发及管理团队 300 多人 。 目前, 开拓者化学 的研发项目已经纳入到礼来的全球药品研发体系中,进而促进了中国参与全球药品研发领域的发展。 上海凯惠医药化工有限公司是专业从事医药化工及医药中间体研发、生产、销售三位一体的综合性企业,拥有近 3000 平方米的工厂基地。设备先进、配套设施齐全的 60000 平方米新厂区将于 2009 年建成投入使用。公司主要从事高附加值新型医药中间体的研发以及工艺优化,精细化工以及原料药合成的研发和工艺优化,特别致力于天然产物、新药研发所需的特种试剂、以及各种糖类化合物放大与生产。
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