CMC Project Lead 面议

广东省深圳市

不限

不限

五险一金
双休
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招聘科室

研发部,项目负责人,科研助理

经验要求

不限

学历要求

不限

薪资要求

面议

工作性质

全职

职称要求

不限

招聘人数

若干

更新时间

2023-01-31

职位描述

POSITION SUMMARY
This CMC Project Lead and Manager will be responsible for formulating company product CMC strategy, planning and execution. He/she will support a few company projects in all CMC aspects of product devel-opment from clinical Phase I to commercialization. The CMC Project Lead will focus on the CMC strategic and operational aspects of the program while also supporting the team in making complex cross-functional decisions (e.g., scenario planning, risk assessment, setting strategic priorities). This role will report to the VP, and director of the company.
Responsibilities
1、Planning, and execution of key program CMC initiatives and mile-stones to support corporate goals.
2、Lead the project CMC team in making complex cross-functional rec-ommendations / decisions
3、Lead and manage project meetings and agenda topics, facilitate dis-cussions, propose/recommend key decisions, and follow up with action items.
4、Ensure alignment of objectives, plans, and activities across various CMC functions (e.g., R&D, Process Development, Analytical Chemistry, QC, QA, Manufacturing, Regulatory Affairs, Supply Chain, etc.).
5、Familiar with operational aspects of the program and produce doc-uments and visual tools to facilitate project tracking and progress (e.g., decision and action logs, planning trackers, timelines, etc.).
6、Ensure that timely and consistent communications regarding pro-gram strategy, status and decisions are made within the team and to other stakeholders, including senior management.
Qualifications
1、Education: a Bachelor of Science (e.g. Biology, Chemistry, Engineer-ing, or Pharmacy) required. Advanced degree (Masters or PhD in a sci-entific discipline) is preferred but not required.
2、3-5 years’experience in a Biotech or Pharmaceutical organization in drug development with expertise/knowledge in such functions as Pro-cess Development, Manufacturing and Engineering, Quality, Analytical Chemistry, Formulation, Supply Chain, Regulatory Affairs
3、Self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges
4、Comfortable working in a fast-paced and dynamic team environ-ment, and can motivate and help others to achieve CMC goals with team efforts
5、Working knowledge of overall drug/biologics development process and familiar with various functional areas and their roles within a bio-tech / pharmaceutical company.
6、Experience in supporting pre-clinical and/or clinical-stage drug de-velopment programs, preferably across different phases (e.g. Phases I–III).
7、Some knowledge of cGMP is desirable
8、Excellent skills of oral and written communications, and sound judgment
9、Ability to multi-task and shift priorities quickly while working under tight deadlines; ability to work under uncertainty
10、Attention to detail, highly organizational, and willingness to learn quickly
11、Good skills in common word processing tools (such as Words, Pow-erPoint, Excel, etc)
12、English proficiency level: passed grade 6 level of English test
13.Title will commensurate with individual’s experience and qualifica-tions

单位介绍

优锐生物成立于2018年,由国际创新药领军人物倪健和国际医药界商业领袖Mark Lotter联合创办,专注于创新药研发、临床试验和转化应用,产品管线聚焦于肿瘤免疫领域,目前已有数项新药分别开展了临床前、临床一期和二期的实验。
公司拥有背景强大的董事会和科学顾问委员会,原约翰霍普金斯大学校长William Brody、经纬中国创始管理合伙人、易趣网创始人邵亦波为公司寻找全球新药资源提供了良好的通道。
我们是全球性的新药研发公司,通过借助于我们在肿瘤免疫领域的深入知识和专注于临床开发的专业能力,来发掘、引进用于治疗癌症的新型药物并快速进行商业化,以最终解决临床上未满足的巨大需求。
优扬起航,锐不可挡,

优锐生物成立于2018年,由国际创新药领军人物倪健和国际医药界商业领袖Mark Lotter联合创办,专注于创新药研发、临床试验和转化应用,产品管线聚焦于肿瘤免疫领域,目前已有数项新药分别开展了临床前、临床一期和二期的实验。
公司拥有背景强大的董事会和科学顾问委员会,原约翰霍普金斯大学校长William Brody、经纬中国创始管理合伙人、易趣网创始人邵亦波为公司寻找全球新药资源提供了良好的通道。
我们是全球性的新药研发公司,通过借助于我们在肿瘤免疫领域的深入知识和专注于临床开发的专业能力,来发掘、引进用于治疗癌症的新型药物并快速进行商业化,以最终解决临床上未满足的巨大需求。
优扬起航,锐不可挡,为人类健康事业奋斗,我们在路上。诚邀你一起同行。办公地址位于:深圳市坪山和南山区。

医直聘安全提示

医直聘直聘严禁用人单位做出任何损害求职者合法权益的违法违规行为,包括但不限于扣押求职者证件、收取求职者财物、向求职者集资、让求职者入股、诱导求职者异地入职、异地参与培训等,您一旦发现此类行为,请立即举报

工商信息

企业全称

优锐生物医药科技(深圳)有限公司

注册资本

140.45万美元

法人代表

倪健

成立时间

2018-11-08

经营状态

存续

企业类型

有限责任公司

职场助手

简历优化

优化简历,涨薪34%

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工作地址

广东省深圳市坪山新区深圳市坪山区坪山街道坪山大道2007号创新广场A座1505单元

公司基本信息

生物药企

50人以下

2个在招职位

职位百科

项目负责人

顾名思义,项目负责人就是指一个项目的负责人,只有一个,是负责建设项目的管理人员。

科研助理

科研助理主要是从事项目的研究以及工程或试验技术和科研辅助的人员,在高校参与教授的研究项目,并承担部分科研工作的研究生。是在2013年公布的教育学名词。

研发部/临床研究员

临床研究员是医疗行业中较为常见的岗位,主要负责组织相关项目的临床监察,也被称为临床监察员,需要具备GCP(药物临床试验质量管理规范)证书。