东莞 [切换城市] 东莞招聘东莞生物/制药/医疗器械招聘东莞医药技术研发管理人员招聘

Analytical Director

泰州越洋医药开发有限公司

  • 公司性质:民营公司
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2017-06-27
  • 工作地点:泰州
  • 招聘人数:1人
  • 工作经验:10年以上经验
  • 语言要求:英语 精通
  • 职位月薪:30-40万/年
  • 职位类别:医药技术研发管理人员  药品生产/质量管理

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 sites
2) Authors and directs the creation of all laboratory SOPs and laboratory quality control system
3) Directs activities of multiple groups to ensure the efficient functioning and high quality output of analytical research and development functions to support product development
4) Creates and implements policies and procedures to assure that IND/AND/ANDA timetables are met
5) Authors and directs the compilation of analytical CMC documents consistent with scientific and regulatory requirements
6) 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 inspections
8) Responsible for approval of all analytical development and stability reports and transfer of analytical methods to contract laboratories
9) Interacts and negotiate with product development and executive level management to create and administer broad-based analytical chemistry research/development direction
10) 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 activities
11) 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 personnel
12) Stays abreast of leading edge on concepts in area of responsibility
13) 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 submissions
14) Selects and approves CROs for bioanalytical assay
15) Qualifies and audits contract manufacturing and analytical service facility
16) Reviews in-licensing opportunities and conducts due diligent from quality and technical perspective and makes recommendation
17) Establishes and manages capital, project and manpower budgets for the department, which include AR&D, stability, QC and technical services function of the company

Requirements:
1) PhD/MS in Analytical Chemistry or relevant scientific discipline§ 10+ years’ experience within analytical development function/quality control in the pharmaceutical industry
2) 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 skills
5) Thorough knowledge of cGMP/GLPs in the pharmaceutical industry
6) 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

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公司介绍

越洋医药成立于2011年底,总部坐落于广州,在泰州和美国圣地亚哥拥有全资子公司。公司由***特聘专家(创业类)闻晓光博士创办,现拥有6名全职欧美海归博士(其中2名***特聘专家)和10多名本土人才为骨干的研发团队,2017年入选第五批国务院侨办“重点华侨华人创业团队”。 越洋医药是一家以特色平台技术为核心、以满足临床未满足的需求为驱动力的国际化改良型新药研发公司,主营业务是应用自主创新和通用缓控释技术开发针对美国市场的NDA(505(b)(2)申报路径)和中国市场的新药(化药2类)以及中美高难度仿制药。

目前,公司独立自主在研8个国际首创新药及16个中美仿制药(含首仿药),在美国和中国同步开展药物研究和临床试验。越洋医药已获得5个美国新药临床试验许可(IND),1个中国新药临床试验许可和1个中国台湾新药临床试验许可,已完成5个新药的人体药动学研究,正在计划开展5个新药的人体试验;并共完成了15个缓控释仿制药的人体试验。越洋医药已自主开发出多项全球首创的药物缓控释平台技术及产品,共获得国内外授权12项专利,其中PCT专利3个(美国,日本,欧盟多个国家和地区授权)。