Director of Manufacturing Science and Technology (MS&T)

面议

南京市

刷新时间：2021-04-23

职位描述

   Provides direct coaching, mentoring and development to each member of the MS&T team both in
execution of responsibilities and in personal development.
 Leading tech transfer from internal or external process development. Develop and translate
process knowledge and understanding into manufacturing controls strategy (product, process,
materials, environment, etc) to ensure successful tech transfer and manufacturing, resolve
complex process/product issues
 In support of setting up manufacturing strategies and trouble shootings for clinical manufacturing
and commercial manufacturing. Technical support & training on the shop floor.  Characterize manufacturing process by using State of Art technology such as scale down models to
support product registration and life cycle management.
 Translate GMP manufacturing expertise into risk assessment based decisions for process design
and operations, to improve the probability of success, time and cost.
 Direct the manufacturing process changes, process validation, discrepancy and investigation
evaluations, change control, process data review, continuous process improvements and
regulatory submissions. Lab work may be required in order to resolve investigations and/or
demonstrate proposed process changes.

   Responsible for authoring technical reports, process description, manufacturing instructions,
process validation documents, and portions of regulatory submissions at existing and new
manufacturing sites, for new pipeline products or process changes.    

   为MS&团队的每一位成员提供直接的培训、指导和发展，包括职责执行和个人发展。领导内部或外部工艺开发的技术转移。将工艺知识和理解转化为生产控制策略(产品、工艺、材料、环境等)，以确保成功的技术转移和生产，解决复杂的工艺/产品问题，为临床生产和商业生产制定生产策略和问题解决提供支持。技术支持,在车间进行培训。使用最新的技术来描述制造过程，例如缩小模型来支持产品注册和生命周期管理。将GMP制造专业知识转化为基于风险评估的工艺设计和操作决策，以提高成功的可能性、时间和成本。指导生产过程变更、过程验证、差异和调查评估、变更控制、过程数据审核、持续过程改进和法规提交。可能需要实验室工作来解决调查和/或演示拟议的工艺变更。

负责撰写技术报告、工艺说明、生产指导书、工艺验证文件，以及现有和新法规提交的部分生产基地，用于新管道产品或工艺变更。

Strong leadership skills; strong communication, technical writing, organizational and interpersonal
skills. Demonstrates critical thinking skills in problem solving and decision making. Attention to
detail and high level of accuracy. The capacity to inspire and motivate the team in the
achievement of specific objectives, and ultimate responsibility.
 In depth knowledge of current Good Manufacturing Practices and China/US/EU regulations. Prior
experience in either design, qualification, start-up or initial Mfg. facilities preferred. CAT-T
production experience a Plus.
 Demonstrated experience in process characterization and product development, technology
transfer, continuous improvement and change management.
 Demonstrated ability to build effective and efficient teams, and drive change within
organizations. Motivated and able to work independently as well as in teams. Excellent
organization and communication skills in Chinese and English.
 Experience with statistics in the areas of statistical process control, modeling, and data
management is a plus
 MS/PhD in Biological/Biochemical Science/Bioengineering/ Related Field with Minimally 10+ years
of biotech industry experience in process development, manufacturing and Process
Validation. Experience with manufacturing support, current Good Manufacturing Practices,
China/US / EU regulations, supervision.

  强有力的领导技能;良好的沟通、技术写作、组织和人际交往能力。具有解决问题和决策的批判性思维能力。注重细节和高度的准确性。能够激励和激励团队实现特定目标，并负有最终的责任。对现行的良好制造规范和中国/美国/欧盟法规有深入的了解。有设计、认证、启动或初始制造经验。设施优先。有CAT-T制作经验者优先。在工艺特性、产品开发、技术转让、持续改进和变更管理方面有丰富的经验。有能力建立高效的团队，推动组织内部的变革。积极主动，能够独立工作和团队合作。优秀的中英文组织和沟通能力。在统计过程控制、建模和数据管理领域有统计学经验者优先考虑生物/生化科学/生物工程/相关领域的硕士/博士学位，至少10年以上生物技术行业过程开发、制造和过程验证经验。有生产支持、现行良好生产规范、中国/美国/欧盟法规、监管经验。  

其他要求

招聘人数：1人
职能类别：生产/质量

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。