Cell Culture, (Sr./Principal) Investigator（北京）

面议

市辖区博士及以上

刷新时间：2022-01-21

职位描述

职位描述

Responsibilities (including but not limited to)

•Provide technical leadership, management, oversight and strategic guidance for early and late stage programs including process development, scale up, tech transfer, scale-down model, process characterization, process validation and BLA-enabling activities.

•Author and review CMC sessions for regulatory submissions

•Oversee and define project scope and ensure successful delivery regarding technical quality, timeline and budget

•Work with cross-functional teams and support senior leadership in defining and executing against short-term and long-term strategic goals

•Establish and maintain an understanding of current trends and emerging cell culture process technologies

•Apply innovative thinking and technical knowledge to design experiment and analyze data.

•Ensure well-organized, clear and complete records of all activities across areas of responsibility

•Manage and mentor junior staff in the cell culture process development group

任职条件

Requirements:

•Requires a PhD with 6-10 years of cell culture process development leadership experience in biotech industry

•Significant experience in the areas of cell culture process development, scale up of bioreactors and GMP manufacturing, process characterization, tech transfer, process validation and BLA-enabling activities

•Experience in preparing and defending regulatory documents (BLAs/INDS)

•Knowledge of cGMP regulations

•Strong experience and knowledge in process validation highly desired

•Self-motivated, assertive, and self-confident with the ability to act with urgency and passion

•Excellent team building, leadership and management skills

•Strong technical/analytical skills to identify and solve problems

•Proven ability to work with a high level of integrity, accuracy, and attention to detail

•Strong organizational skills for high productivity, innovation and priority-setting to complete assignments on time and on budget

•Excellent oral and written communication skills

•Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions

•Resourceful, creative, enthusiastic, and results-oriented

其他要求

招聘人数：10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。