（CPB）活性分析负责人Assistant Director/Associate Director/Director of Immunology Group

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刷新时间：2021-07-16

职位描述

Assistant Director/Associate Director/Director of Immunology Group–CPB Analytical Development & Quality Control
The Assistant Director /Associate Director/Director of the immunology group within the CPB Analytical Development & Quality Control Department has the responsibility of leading a group of analytical development scientists & quality control analysts for the development, improvement, and execution of a variety of immunological, biochemical related methods for the analysis of protein, antibody, peptide products, samples in their concentration, identity, impurity profiles, and other relevant biochemical and immunological characteristics using a variety of immunological, biochemical approaches, methodologies. 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 immunological, analytical methods for supporting GMP manufacturing, QC testing of therapeutic antibody, protein and peptide products for various clients, customers.

Major responsibilities include:
 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;
 Lead the group for the development, transfer, validation and execution of various immunological, 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
 Review, Draft, and approve SOPs related to the areas of analytical group functions;
 Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions
 Manage internal and external projects, testing tasks, contracts effectively and efficiently
 Interact and collaborate with internal groups, departments, as well as external clients, customers effectively

 Lead the group for effective deviation, OOS investigation in a timely manner;

Manage group member performance effectively
 Prepare technical registration documents for regulatory submission.
Requirements:
 Ph.D in biochemistry, immunology or other relevant fields with at least 5-10 years of
relevant experience;
 Has indepth experience and working knowledge in the use of multiple biochemical
and immunological technologies, methodologies for the analysis of protein,
antibody, antibody conjugates, and peptide products, and complex protein samples;
methods include but not limited to ELISA based binding assay, Host cell protein (HCP)
assay, host cell DNA assay, residual protein A assay, plus other impurity assays using
immunological detection tools like antibodies, one dimensional and two
dimensional gel electrophoresis techniques with western blot.
 Indepth understanding, knowledge, and experience in analytical method
development, validation for therapeutic protein, antibody, and antibody conjugate,
peptide products

Demonstrated capability of developing various analytical methods independently
for therapeutic protein, antibody, antibody conjugate, petide products
 Demonstrated capability of leading & managing a group of analytical scientists for
the execution of multiple projects, testing activities in a fast-pace environment
 Solid GMP knowledge, experience, adequate knowledge of Quality Control
operation
 Good oral and written communication skills in English and Chinese
 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：药物分析/药品检验

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。