锦鲤求职

药明生物

QC 项目管理 QC Function Lead

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岗位描述

岗位职责

As QC point of contact and

project management personnel, to participate in projects from early product development stage

to final commercial production. Work with the CMC team of projects and

understand the scope of the project and all vital aspects related to QC

activities

Build effective partnership

with other internal teams to move project through all phases of the development

and commercial stages.

Serve as the liaison of QC

and communicate with the client and other stakeholders in a project. Build and

maintain excellent relationships with clients.

Gather and convey project

information to the QC team and ensure that all team members understand the

scope and deliverables of the project

Prepare and track the

schedule of QC activities and ensure that the QC part of the project is carried

out on time

Prepare GMP documents,

including but not limited to release and stability protocols, in-process

sampling and testing protocols, special study protocol per client’s

requirement, study reports, etc.

Complete other tasks assigned

by supervisor

Ensure that the project is

carried out in compliance with regulations

作为QC联络人和项目管理人员,参与从早期产品开发到最终商业生产的项目。与CMC项目团队合作,了解项目范围以及与QC活动相关的所有重要方面

与其他内部团队建立有效的伙伴关系,以推动项目从进入开发到商业生产的所有阶段的有效实施。

作为QC的联络人,与项目的客户以及其他利益相关者沟通。与客户建立并保持良好的关系。

收集并向QC团队传达项目信息,并确保所有团队成员了解项目的范围和可交付成果

制定并跟踪QC活动时间表,确保项目的QC部分按时进行

准备GMP文件,包括但不限于放行和稳定性方案、过程取样和检测方案、根据客户要求的特殊研究方案、研究报告等。

完成主管分配的其他任务

确保项目的实施符合法规要求

岗位要求:

教育程度/经验Education background/ Experience

Bachelor or MS in

Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology,

Biological Engineering, or related fields. Degree of Master, or a Degree of

Bachelor with at least 2 years of pharmaceutical industry experience

分析化学、生物化学、微生物学、生物学、分子生物学、生物工程或相关领域学士或硕士。 硕士学位,或具有至少2年医药行业工作经验的学士学位

其他要求(比如工作时间或特殊技能等)Other requirements (e.g.: working time, special skills)

Knowledge and expertise in at

least one of the following fields:

Biochemical assays such as

ELISA, cell based assay, qPCR, Western blot, enzyme activity testing;

Separation assays such as HPLC, CE, gel electrophoresis; Biophysical assays

such as MS, spectroscopy (UV, FTIR, CD, fluorescence, etc.), DSC

拥有以下至少一个领域的知识和专业知识:

生物化学试验,如ELISA、基于细胞的试验、qPCR、蛋白质印迹、酶活性检测;分离试验,如HPLC、CE、凝胶电泳;生物物理试验,如MS、光谱学(UV、FTIR、CD、荧光等)、DSC

Outstanding oral and written

communication skills in both English and Chinese

Critical thinking, scientific

reasoning and problem solving skills

Good project management, time

management, and multitasking skills

Strong interpersonal skills

with the ability to work effectively with a wide variety of professionals.

Good computer operation

skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.

优秀的中英文口语及书面沟通能力

批判性思维、科学推理和解决问题的技巧

良好的项目管理、时间管理和多重任务处理的技能

较强的人际交往能力,能够与各种专业人员有效合作。

良好的计算机操作技能,Microsoft Word、Excel、PowerPoint等工作软件使用水平中等以上。

质量安全方向的申请准备

先核对岗位要求与自己的经历,再准备档案、投递和面试。

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