合成工艺开负责人

面议

市辖区

刷新时间：2024-04-25

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 CMC managing all regulatory CMC aspects of
oligonucleotide therapeutics in our pipeline throughout their lifecycle. In this role, you will have an
exciting opportunity to build entire CMC team and manage both internal CMC function and external
CDMO activities.
Responsibilities
Build internal CMC team. Manage both internal and external CMC functions.
Collaborate/manage internal and external technical teams. Lead and drive process chemistry and
manufacturing activities both internally and at CDMO partners.
Provide regulatory support to CDMOs.
Plan, prepare and review CMC components of all regulatory documents.
Coordinate submission in collaboration with Regulatory Affairs.
Lead the preparation for and conduct of formal CMC meetings with regulatory health authorities.
Skills/Knowledge/Competencies Required
Experience in Process chemistry development/manufacturing of oligonucleotide drugs preferred.
5+ years relevant regulatory CMC experience, preferably in oligonucleotide drug development.
Knowledge of pharmaceutical drug substance/drug product CMC development, GMP manufacturing,
and understand phase appropriate development concept and strategies.
Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
Experience with primary authoring of drug substance, drug product and analytical sections.
Prior experience with authoring, submission, and approval process of a major marketing application is a
plus.
Demonstrated ability for critical thinking, proactively identifying issues, being able to communicate risks,
and developing and executing contingency plans.
Compensation
Competitive salary, benefit and stock plan.
公司地点：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司。诚信招募 CMC 负责人。在这个职位
上，您将会有机会来组建整个 CMC 团队，领导公司的 CMC 部门和管理 CDMO 合作。
职责描述
组建和管理 CMC 团队；
负责新的寡核苷酸药物开发工艺评估及优化，中试生产，工艺与分析方法转移，临床样品生产，
IND 申报项目；
为 CDMO 合作伙伴提供 CMC 的**和支持；
主导 CMC 部分的申报资料撰写、审核，以满足 IND/ CTA/NDA 的申报时间及资料要求；
负责准备和主持与 NMPA，FDA 及其他国家医药卫生管理机构的 CMC 正式 会议。
任职要求
有相关的原料药、成品药 GMP 制造和 CMC 经验，特别是寡核苷酸药物制造和化学工艺优化经验
者优先；
熟悉中美新药 CMC 相关技术指导原则、法规、质量管理及风险控制策略、申报流程；
有主导过申报资料撰写审核经验者优先。
具备很强的团队协作管理能力
薪酬福利
我们提供有竞争力的薪酬、福利和股票计划。  &nbs*****>

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。