Analytical Director 泰州

月薪： 30-40万/年

该公司所有职位
  • 10年以上经验
  • 招1人
  • 英语精通
  • 11-09 发布

职位描述

职位描述： As a director for analytical sciences in the company, you will be responsible for directing and managing the establishment of laboratory operation and laboratory quality system for analytical research & development to support product development internally and externally, and quality control operation to support clinical studies and commercial launches.Responsibilities:1)Management of all analytical method development, validation and transfer to external contract manufacturing sites2)Authors and directs the creation of all laboratory SOPs and laboratory quality control system3)Directs activities of multiple groups to ensure the efficient functioning and high quality output of analytical research and development functions to support product development4)Creates and implements policies and procedures to assure that IND/AND/ANDA timetables are met5)Authors and directs the compilation of analytical CMC documents consistent with scientific and regulatory requirements6)Leads company contact with the FDA on analytical and stability issues.7)Serves as technical spokesperson on analytical and chemistry-related issues for the company and represents Overseas Pharmaceuticals during FDA inspections8)Responsible for approval of all analytical development and stability reports and transfer of analytical methods to contract laboratories9)Interacts and negotiate with product development and executive level management to create and administer broad-based analytical chemistry research/development direction10)Directs and participates in the design, modification, development and implementation of company practices and policies that affect not only analytical development activities but companywide product development activities11)Responsible for achieving and maintaining a technological and compliance edge in the department by acquiring new equipment, procuring resources and establishing a robust training and development program for department personnel12)Stays abreast of leading edge on concepts in area of responsibility13)Approves and issues all analytical CMC documents, including study report, stability report, CoAs of all material release, validation report and specification of all raw materials and products to Regulatory Affairs for IND/NDAANDA submissions14)Selects and approves CROs for bioanalytical assay15)Qualifies and audits contract manufacturing and analytical service facility16)Reviews in-licensing opportunities and conducts due diligent from quality and technical perspective and makes recommendation17)Establishes and manages capital, project and manpower budgets for the department, which include AR&D, stability, QC and technical services function of the companyRequirements:1)PhD/MS in Analytical Chemistry or relevant scientific discipline§ 10+ years’ experience within analytical development function/quality control in the pharmaceutical industry2)Scientific knowledge and experience in analytical/organic chemistry in drug development and associated analytical requirements throughout the discovery/development/commercial continuum.3)Maintains current awareness in areas of expertise.4)Excellent leadership, managerial and problem-solving skills5)Thorough knowledge of cGMP/GLPs in the pharmaceutical industry6)Thorough understanding of the regulatory requirements in CMC development?7)Excellent written and communication skills to effectively represent the analytical issues with internal project and CMC teams, external contract organizations and senior management. 职能类别： 医药技术研发管理人员 药品生产/质量管理 关键字： drug analytical director

联系方式

江苏省泰州市中国医药城药城大道一号陶弘景路8号双子楼1210室

公司信息

泰州越洋医药开发有限公司www.overseaspharm.com于2011年12月成立于江苏省中国（泰州）医药高新区。公司由“国家千人计划特聘专家”闻晓光博士创立，研发团队核心成员及其美国合作伙伴曾就职于GSK、Pfizer、Teva、Johnson等跨国药物公司，拥有先进的药物开发理念和成功的缓控释制剂产品开发经验。 越洋医药是一个特色技术平台公司，主要从事缓控释平台技术建设及缓控释新药(505（B）(2)-NDA)和仿制药产品(505（j)-ANDA)的开发。公司的产品定位于中美两国市场/中美欧三个地区市场，实现中国由原料药出口向制剂产品出口转型升级，实现高端制剂国产化，高额利润本土化。为患者提供新药以满足还未满足的临床需求。越洋关爱人类健康，世界关注越洋技术。

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企业入驻日期： 2017-11-09

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