生物制药企业:Head of CMC 苏州

月薪： 5-9.9万/月

该公司所有职位
  • 5-7年经验
  • 博士
  • 招1人
  • 12-01 发布
  • 五险一金
  • 餐饮补贴
  • 通讯补贴
  • 年终奖金
  • 绩效奖金

职位描述

职位描述： The Head of CMC will lead the CMC function ensuring that appropriate scientific, regulatory, and quality standards are followed across process development, analytical chemistry, formulation development, supply chain activities, and manufacturing production. This position reports to CEO directly.Required Skills1.Leads and oversees the CMC function consisting of USP/DSP process development, analytical development, formulation development, pilot manufacturing， and supply chain.2.Oversees the preparation and management of CMC content plans and budgets. Collaborates with CMC team members to negotiate and administer contracts. Collaborates with other functional groups on CMC matters (e.g., quality, regulatory affairs.).3.Provides mentoring and development of staff.4.Ensures all development, manufacturing, and process validation activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant IND submissions，clinical trials， and marketing applications.5.Reviews Technical/Quality agreements to ensure that outsourced activities are conducted in compliance with cGMPs and exercise appropriate oversight of the activities. Supports CMC team members in management of contractors and outsourced CMC activities，leading cross-functional projects, planning and delivering results within project deadlines.6.Writes, reviews and edits CMC sections and provides input into regulatory submissions and regulatory approvals.7.Participates in and represents company on CMC in meetings with global regulatory agencies. Presents CMC information and manufacturing plans/updates to CEO and business partners, as required.Required Experience1.PhD in pharmaceutical sciences, chemical engineering, or related scientific discipline and a minimum of 7 years of process/product development and/or commercial manufacturing experience in biologic industry, particularly in therapeutic antibody field.2.Managerial experience with a team of CMC development scientists and/or engineers.3.Demonstrated ability to manage Contract Manufacturing Organizations (CMOs) spanning all phases of development including contract negotiation.4.Demonstrated definition of CQAs and CPPs, and effective use of process risk assessment tools (e.g., FMEA).5.Demonstrated expertise in manufacturing process validation. Experience with implementation of post-approval changes is preferred. Experience working in big pharma is preferred。 职能类别： 医药技术研发管理人员

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公司信息

苏州独墅湖高教区就业和培训指导中心成立于2008年5月5日，是独墅湖高教区发挥人才功能的重要载体，由就业和培训指导中心负责筹备和运作；力争3-5年内成为华东地区一流的最新型的人才交流市场，为高教区成为一流的科教创新区提供强大的人才支持。专业的招聘服务猎头招聘：为企业客户、高等院校及科研机构提供“小而精”的订单式人才推荐服务。现场招聘：协助客户开展校园招聘及专场招聘。远程招聘：通过视频面试、电话面试等远程服务，缩短优秀人才和企业客户之间的空间距离。人才测评：提供人才招聘中所需要的人才评估工具及测评报告。人事外包：为成长型公司提供人事档案关系办理、社保公积金缴纳等代理服务。

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