制剂生产负责人

0-80万元/年

市辖区

刷新时间：2024-04-24

职位描述

  POSITION SUMMARY:
An ideal candidate will represent ZhenGe Drug Product Manufacturing Sciences and Technology (MS&T) group on project teams as a subject matter expert (SME). The candidate should be able to apply sound scientific and engineering principles to solve manufacturing problems and drive projects to a successful completion within defined timelines. The Drug Product MS&T Scientist/Engineer will successfully transfer and enroll biopharmaceutical processes into the new Pilot & Commercial Manufacturing Facility in Shanghai. Candidate will coordinate multi-functional activities and resources relating to clinical and commercial drug product manufacturing process The candidate should be able to work independently and with teams. The candidate should also possess excellent communication skills, while effectively collaborating and influencing cross functional partners to support ZhenGe MS&T objectives. The candidate will be involved in cross functional activities including, Technology transfer, Validation, Supply/chain, Quality assurance, Quality Control, Compliance, Change management and Product life cycle management as required.
JOB RESPONSIBILITIES:
Participate in technology transfer activities for early to late-stage clinical manufacturing programs and commercial programs.
Have technical insight on drug product manufacturing (DS formulations to packed product). Candidate will have experience in liquid, lyophilized in vials and syringes.
Participate in facility fit activities including, scale-up/scale-down calculations, gap assessment and risk assessments
Participate implementing a Drug Product control strategy during technology transfer
Prepare, review technical documents including supporting batch records, protocols, SOPs, formulation/solution/media records, component specifications, project reports, and engineering specifications.
Participate in process validation activities
Participate in deviation investigations
Provide person in plant support during cGMP production.
Compile and analyze process data, experimental study data
Assist with generating Bill of Materials (BOM)
MINIMUM REQUIREMENTS:
Good interpersonal and communication skills, verbal and writing skills in English / Chinese.
Development and operations experience/expertise (cGMP) in drug product biopharmaceutical Master degree in Science or Engineering with minimum of 7 years industry experience
Expertise in drug product processing techniques and equipment in biologics at lab scale and at manufacturing scale.  

其他要求

招聘人数：1人
语言要求：英语
职能类别：生产技术员

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。