GLP QA

面议

南通市

刷新时间：2021-02-24

职位描述

Job Description: Assistant Director/Associate Director/Director, Analytical Chemistry Group, Analytical Center & QC

Job functions:
The person in this position will lead the Analytical Center & QC at CPB based in Zhangjiang, Shanghai. Main responsibilities include:
The Assistant Director & Associate Director & Director of the protein analytical chemistry group has the responsibility of leading a group of analytical development scientists & quality control analysts for the development, improvement, and execution of a variety of biochemical and analytical methods for the analysis of proteins, antibodies, peptides, as well as chemicals, excipients., etc, in their concentration, size, identity, purity, impurity, product heterogeneity, conformation, structure, and other relevant chemical, biochemical, and biophysical characteristics. Besides leading the group to support various process development activities he/she will also have the responsibilities for transferring, validating and implementing a variety of analytical methods for supporting GMP manufacturing, QC testing of therapeutic antibody, and protein products for various clients, customers.

Major responsibilities include:
1. Lead a group of analytical development scientists & QC analysts for conducting assigned projects & tasks in the areas described above to meet company, project goals, expectations in a tight time line;
2. Lead the group for the development, transfer, validation and execution of various analytical methods for supporting cell line development, as well as upstream and downstream process development and GMP manufacturing activities for therapeutic antibody and protein drugs, products for clients, customers
3. Review, Draft, and approve SOPs related to the areas of analytical group functions;
4. Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions
5. Manage internal and external projects, testing tasks, contracts effectively and efficiently
6. Interact and collaborate with internal groups, departments, as well as external clients, customers effectively
7. Write, review and approve technical documents, validation and other QC related documents, and make presentations for internal company use as well as for external clients, customers;
8. Lead the group for effective deviation, OOS investigation in a timely manner;
9. Manage group member performance effectively
10. Prepare technical registration documents for regulatory submission.

Requirements:
1. Ph.D in biochemistry, analytical or other relevant fields with at least 5-10 years of relevant experience;
2. Has indepth experience and working knowledge in use of multiple analytical technologies, including but not limited to UV/VIS, HPLC/UPLC, Capillary electrophoresis (CE), DSC, DLS, CD, FTIR for the analysis of proteins, antibodies, peptides, chemicals, excipients.
3. Indepth understanding, knowledge, and experience in analytical method development, validation for therapeutic protein, antibody products
4. Demonstrated capability of developing various analytical methods independently for therapeutic protein, antibody products
5. Demonstrated capability of leading & managing a group of analytical scientists for the execution of multiple projects, testing activities in a fast-pace environment
6. Solid GMP knowledge, experience, adequate knowledge of Quality Control operation
7. Good oral and written communication skills in English and Chinese
8. Be able to work effectively in a team oriented and fast pace environment

其他要求

招聘人数：1人
职能类别：QA工程师

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。