大分子分析总监Director of Analytical Development & Protein Characterization Group （上海）

面议

市辖区

刷新时间：2023-10-23

职位描述

The Director of Analytical Development & Protein Characterization Group is responsible for leading the group for carrying out analytical development, transfer activities, as well as protein/antibody characterization activities for biologics drug products. He / she is mainly responsible for leading the team to develop a variety of analytical methods for supporting QC testing of biologics products, supporting biologics drug product characterization using a variety of analytical characterization techniques, methods, including but not limited to liquid chromatography, capillary electrophoresis, mass spectrometry and other biophysical, biochemical techniques.
Main responsibilities include:
1.Lead the team of analytical scientists to develop analytical methods and transfer the methods to Quality Control organization for testing biologics drug products
2.Effectively manage the team to carry out various product/antibody characterization work using a variety of techniques/methods, including but not limited to mass spectrometry, liquid chromatography（HPLC, UPLC）, capillary electrophoresis (CE)， LC-MS, and other biophysical, biochemical techniques in order to support the development of CMC biologics drug products for ******s, as well as to support contract testing of products, samples from ******s to meet the needs of ******s for various purposes.
3.Effectively manage the work flow of analysts and instrument use in order to achieve the highest working efficiency
4.Effectively manage and maintain the analytical instruments in the regulated environment, ensuring good and sustainable operating conditions for the instrument to meet the analytical testing requirements, project needs
5.Write and approve technical reports, documents for the development and characterization of biologics products, samples for ******s
6.Communicate closely with internal teams, including QC, Process development, business development, as well as project management teams for effective execution of all of the contract projects
7.customers
8.Effectively manage the performance of team members
9.Conduct hiring of new team members, ensuring team’s adequate analytical capacity for meeting project execution needs
10.Conduct technical interaction and communication, presentation with internal teams and external ******s



Requirement:
1．Ph.D. with at least 10 years of experience in protein chemistry, analytical chemistry, mass spectrometry, biochemistry, biophysics or other related fields
2．In depth experience and knowledge of protein chemistry and mass spectrometry, biochemistry, analytical chemistry, biophysical analysis. Experience with IND filing applications of biologics drug products (NMPA, FDA)
3．Familiar with regulatory & pharmacopeia requirements (ChP, USP) with regard to analytical method development, transfer, and validation
4．Familiar with and master the following analytical techniques for biologics product characterization, including but not limited to HPLC， UPLC， CE， mass spectrometry / LC-MS, liquid chromatography. Familiar with Biacore, DSC, CD, etc
5．Ability to lead and manage the analytical team, be able to execute multiple projects and related analytical activities in a fast-pace working environment.
6．Excellent communication skills in both Chinese and English, including oral and written communication skills
7．Able to work effectively in a team work and fast environment.

其他要求

招聘人数：1人
职能类别：CMC

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。