上海招聘

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.

    越洋医药成立于2011年12月，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，为国务院侨办第五批“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。主营业务是针对尚未被满足的临床需求，应用自主创新和通用缓控释平台技术，开发适应美国NDA/505(b)(2)、中国（化药2类）及全球市场的新药。
    公司专注于口服固体缓控释技术、缓控释新药和高难度仿制药等领域，在美国、中国、加拿大、印度、中国台湾等多个国家和地区开展药物研究和临床试验，目前已取得一定成绩。越洋医药已获得 7 个美国新药临床试验许可（IND），2 个中国新药临床试验许可和 2 个中国台湾新药临床试验许可，已完成 5 个中美 IND 的申请，在审评中；已完成 12 个新药的人体药动学研究，试验结果达到预期，大大降低了下一阶段药物开发的风险；已完成 1 个新药 NDA 批次生产；已完成了 19 个缓控释仿制药的人体试验，其中 9 个通过预 BE，3 个通过正式 BE；已完成 4 个中美 ANDA上市许可申报，其中 1 个美国 ANDA 已于 2020 年 6 月 11 日获批上市，3 个在审评审批中，预期 2021 年获批上市。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 15 项专利，其中 PCT 专利 4 个（美国、日本、欧盟多个国家和地区授权）。
    截止目前，越洋医药是获得国家药品审评中心2.2类缓控释新药临床批件的仅6家公司之一；是行业分析机构推荐的仅两家改良型新药公司之一。公司2018年获得广州市创新领军团队项目，2018年、2019年连续两年被评为粤港澳大湾区生物科技创新企业50强。2016年在第五届中国创新创业大赛生物医药行业总决赛中，越洋医药获得全国第三名（全国共3924家企业参加该项大赛）。2014年越洋医药凭借口服缓控释制剂技术获得克莱斯勒杯第四届黑马大赛冠军。
   如果你有产品开发的激情，
   如果你有投身研发工作的毅力，
   如果你有独立开创平台技术和产品的勇气，
   如果你有和创业公司共同成长、成熟、成功的决心……
   欢迎你加入越洋医药——
   这里有国际首创的缓控释平台技术，
   这里有国际最先进的制剂设备和分析仪器，
   这里有经验丰富、客观严谨的海归科学家，
   这里有全新的文化理念和管理方法，
   在这里，你可以为人类健康提供解决方案，
   在这里，你可以***限度地实现自己的价值，
   在这里，你可以看见自己的梦想变成现实，
   在这里，你可以见证公司的明天、行业的未来！
   越洋医药——离梦想和成功最近的地方！