质量QCHead of CMC Analytical development CMC分析主管

面议

市辖区

刷新时间：2021-10-27

职位描述

Location: Shanghai, China (can work in USA or other countries in the early days)
Summary:
Argo Biopharmaceuticals, a startup biotech company focusing on oligonucleotide drug discovery and development, has an opening for the head of analytical to build and lead entire analytical team. The position has the unique opportunity to create a vision and implement the strategy that will make a major impact in the oligonucleotide drug discovery and development.
Responsibilities
Responsible for leading analytical method development for oligonucleotide therapeutics by working closely with our process development and production groups.
Developing novel methods, and improving the characterization of our DS and DP products throughout development.
Give support QC with the transfer of methods to contract labs for GMP testing and the creation an internal QC capability.
Manage all aspects of the analytical development to ensure reliable internal testing is performed, including the management of methods, SOPs, protocols and method development reports.
Work cross­functionally with the Research, Process Development, Quality Control, and Manufacturing teams to ensure consistent characterization of Argo Bio’s RNAi drug products from research to the clinic, including the drafting and review of CMC sections and supporting documents for regulatory filings.
Qualifications
Ph.D. in analytics with relevant post-Ph.D. experience in Biotech/Pharma with an excellent track record. exceptional Master degree also considered;
Extensive knowledge and practical skill of modern analytical techniques and tools, such as HPLC, UPLC, HRMS, LCMS;
Experience in IPC and release of manufacturing;
Experience in Oligonucleotide analytical and bioanalytical is preferred;
General CMC experience (GMP, SOP, QA etc.)
Ability to keep up to date with current developments in the field and implement new practices and technologies to keep the department at the forefront in the industry;
People management experience and skill in leading, motivating, developing and organizing personnel;
Compensation
Competitive salary, benefit and stock plan.

工作地点：中国上海（早期可以以远程办公的方式参加工作）
职位概述：
我们是一家专注于寡核苷酸药物研发的初创生物技术公。诚信招聘分析部门负责人。在这个职位上，您将有机会负责建立和领导整个分析团队并将对公司的寡核苷酸药物管线和研发战略产生重大影响。
职责
通过与我们的工艺开发和生产小组密切合作，负责领导寡核苷酸药物的分析方法开发；
开发新的方法，并在整个开发过程中改善我们的DS和DP产品的特性；
在将方法转移到合同实验室进行GMP测试和建立内部QC能力方面给予QC支持。
管理分析开发的所有方面，以确保进行可靠的内部测试，包括方法、SOP、协议和方法开发报告的管理；
与研究、工艺开发、质量控制和制造团队进行跨职能合作，确保公司的RNAi药物产品从研究到临床的一致性，包括起草和**CMC部分和**文件的支持文件。
任职要求
具有分析学博士学位，并在生物技术/制药业有相关的博士后经验，有良好的业绩。优秀的硕士学位也可以考虑;
对现代分析技术和工具，如HPLC、UPLC、HRMS、LCMS有丰富的知识和实践技能;
有IPC和生产放行方面的经验;
有寡核苷酸分析和生物分析经验者优先;
有项目管理经验者优先;
具有一般CMC经验（GMP、SOP、QA等）;
能够及时了解该领域的最新发展，并实施新的实践和技术，以保持该部门在行业中的领先地位;
具有人员管理经验和领导、激励、发展和组织人员的技能。
薪酬福利
我们提供有竞争力的薪酬、福利和股票计划。

其他要求

招聘人数：1人
职能类别：研发总监/研究院院长

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。