甘李药业招聘
Gan & Lee Pharmaceuticals. is a biotech pioneer in China with several human therapeutic products on the market. The company has fully integrated capabilities in research and development, manufacturing, commercial operations and product distribution. We operate in China and many other countries and regions in the world and are experiencing unprecedented growth driven by strong sales both domestically and internationally.
Our mission is to bring vital medicines in the areas of unmet medical needs to patients around the world. To achieve this goal, we strive to build our company and product portfolio on science, advance products through technology, and excel in quality. That’s why we are expanding our research operations in Beijing, China. We are seeking motivated individuals with advanced training in biological sciences (biochemistry, molecular biology, pharmacology, and biotechnology, etc.) or chemistry to join our exciting drug discovery team and help bring new therapies to life.
All the following open positions are based in Beijing. Compensations will be commensurate with qualifications and experience.
Directors in drug discovery We have several director-level positions in the areas of metabolic disease, oncology, monoclonal antibody technology (hybridoma technology and cell line development) and process chemistry. Qualified individuals should have a PhD in biological sciences or chemistry with at least 5 years’ principal investigator experience in academia or the biopharmaceutical industry. Demonstrated leadership experience in biological research or drug discovery as well as a good track record of productivity in one of the above disciplines is required. A good publication record is preferred.
Research Scientists We have a number of positions at this level. Qualified individuals should have a PhD degree in biological sciences with at least one year’s postdoctoral experience. Industry experience is not required. These individuals must be willing to learn drug discovery technologies to contribute to the overall success of our research organization.
甘李药业简介
甘李药业股份有限公司，成立于1998年，是一家集科研、开发、 生产、销售于一体的高科技生物制药企业。公司在生物合成人胰岛素及其类似物的开发、研制和生产等方面均处于国内外领先地位，是专注于生物合成人胰岛素类似物的专业公司。
1998年创始人甘忠如博士和他的胰岛素小组研制出中国第一支生物合成人胰岛素注射液，被587名两院院士评为中国十大科技进步新闻之一，并获得2002年度国家科学技术进步奖。2001年，甘李药业成功研制出中国第一支超速效人胰岛素类似物速秀霖®；2002年，成功研制出中国第一支长效人胰岛素类似物长秀霖®。
公司从欧美等国家引进了先进的生产设备和分析仪器，按照GMP标准建成了重组人胰岛素及类似物的原料车间及小容量注射剂车间。高密度发酵技术、纯化技术和工业化生产经验，确保公司生产出的每一个产品的安全和优质。
2005年中国第一支超长效人胰岛素类似物－长秀霖®（甘精胰岛素）上市；2007年中国第一支超速效人胰岛素类似物－速秀霖®（赖脯胰岛素）上市。产品自上市以来，销售额和利润连续5年增长，业务也已经拓展到多个国家及地区。
2010年公司引入香港明华风投，成功融资1亿元人民币，完成公司在资本市场的首轮融资。
Corporate Overview
Gan & Lee Pharmaceuticals (Gan & Lee) is a leading biotechnology company in China engaged in the development, manufacturing and commercialization of human therapeutics. Established in 1998 and headquartered in Beijing, Gan & Lee has fully integrated capabilities in research and development, manufacturing, commercial operations and product distribution. Its top line products recombinant human insulin and insulin analogs meet EP and USP quality standards. Gan & Lee operates in nearly 20 countries and regions and is in the process of expanding its operations worldwide. Our mission is to bring vital medicines in areas of unmet medical need to patients around the world. To achieve this goal, we strive to build our company and product portfolio on science, advance products through technology and excel in quality.
A leader in the biotechnology industry in China, Gan & Lee was founded by Dr. Zhongru Gan in 1998 and quickly became a biotechnology pioneer in the production of recombinant human insulin and insulin analogs. Gan & Lee’s success is built on science and advanced by its patented technologies. The company received several national awards for its innovations. In the past several years, Gan & Lee has built a strong competitive edge in the production and commercialization of insulin-based products, emerging as one of the fastest growing biotechnology companies in China. With its established strengths in research and development, regulatory filings and commercial operations, Gan & Lee is well equipped to bring additional human therapeutics to patients with grievous diseases around the world.
Two of Gan & Lee’s key products, Basalin® (insulin glargine) and Prandilin® (insulin lispro), have been consistently driving the company's revenue growth since their launches. With product distributions across nearly 20 countries and regions, Gan & Lee has become one of the top insulin producers in the world. We will continue our growth by investing in R&D and commercial infrastructure with the goal of building a great world-class healthcare company.
工作地点：北京
海外临床项目管理经理
任职资格：
1.仅限医学、临床医学专业，本科以上学历（中级以上职称优先）；
2.英语书面和口语熟练，能够与国外客户沟通自如；
3.两年以上医药行业临床工作经验，有国际多中心临床工作经验者优先；
4.能够策划、实施海外临床试验，并独立完成海外临床文献汇编工作；
5.熟悉FDA、欧盟临床法规，能够审阅符合国际标准的临床方案。负责公司海外临床的项目管理工作。
6.有较强的团队协作能力，具备优秀的沟通交流能力；
Overseas Clinical Project Manager
Qualification
1.Bachelor or above majoring in medicine, clinical medicine (intermediate professional title or above is preferred)
2.Proficient in written and spoken English to be able to communicate with overseas clients smoothly
3.Over 2 years of clinical experience in pharmaceutical industry; the one with international multi-center clinical study experience is preferred
4.Able to propose and implement overseas clinical studies as well as to independently fulfill compilation of overseas clinical literature
5.Knowing well about the regulations and laws with FDA and EU, able to review and approve the clinical protocols in accordance with the international standards; responsible for management of overseas clinical project of the company
6.Having good teamwork ability and excellent communication ability
海外注册部总监
1. 具有生物化学, 生物工程, 生物分析或化学相关的本科及以上学历。本科学历需要有7年以上与注册相关的工作经验, 硕士5年, 博士3年。有在欧美制药企业从事针对欧美市场新药注册相关的工作经验。
2. 了解生物药研发，特别是生物仿制药。有从事欧美生物药企业研发和生产的背景者优先考虑。
3. 从事欧美市场新药注册相关的工作经验，独立完成过IND,CTA,和NDA/BLA/MAA申报材料的撰写。必须具有撰写CMC部分的经验。 具有pre-clinical和clinical部分写作经验者优先考虑。
4. 以具有和FDA和EMA进行直接接触经验者为首选, 接触包括参与FDA/EMA会议, 撰写会议所需要的文件, 代表公司和FDA/CHMP/EMA就研发及注册相关问题进行讨论。
5. 熟悉欧美药物研发注册法规, 熟悉ICH相关的法规。
6. 有欧美地区注册相关的工作经验, 熟悉了解GMP,GLP和GCP。有在欧美药企工厂从事生产和质量经验者优先考虑。
7. 有团队管理经验, 包括招聘, 日常管理和工作评定。
8. 除欧美注册经验外, 有在发展中国家注册生物药的相关经验的为首选。
9. 有筛选, 合同谈判和管理CRO的经验。
10. 精通英语，能够用英语进行沟通交流。
Qualification
1. The qualified candidate should have at least the bachelor degree in biochemistry, bioengineer, bioanalysis, chemistry or related science degree. The advanced degree is preferred. For the bachelor degree, the candidate should have at least 7 years experience in regulatory. The advanced degree can reduce the requirement for the experience, master requires at least five years, Ph.D. at least 3 years.
2. Familiar with the development process for the large molecule drug product, especially the biosimilar drug product. Prefer to have the drug discovery, development or manufacturing experience in the oversee pharmaceitical companies.
3. Hand-on experience in new product registration in US/EU. Have the experience in preparing IND, CTA, NDA, BLA and MAA. The qualified candidate must have the experience in preparing the CMC related sections, prefer to have additional experience in the pre-clinical and/or clinical parts.
4. Prefer the candidate who has the experience in direct communication with FDA/ EMA/CHMP including attending meetings, preparing meeting documents, minutes and representing the company to discuss the regulatory strategy related to the drug development.
5. Familiar with the US/EU/ ICH drug development and registration laws and guidances.
6. Familiar with the GMP, GLP and GCP. Prefer to have the experience in the manufacturing and qulaity control in multi-national pharmaceutical companies.
7. Have the people manager experience including hiring, daily management and performance review.
8. Except for the regulatory experience in US and EU, prefer to have additional experience in biological product registration in emerging markets.
9. Experience in the CRO screening, contract negotiation and management
联系人：赵磊
邮箱：zhaolei#ganlee.com（#=@）
手机：13146563746
电话：010-56965102
启事已在2013年6月9日中国科大手机报中发送。
2013-05-28 上一篇: 苏州瀚海化学招聘 下一篇: UWO 招收硕士或博士生
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