Scientist /Engineer
西安杨森制药有限公司
- 公司规模：1000-5000人
- 公司性质：合资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2019-06-03
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 工作经验：8-9年经验
- 学历要求：本科
- 职位月薪：10-20万/年
- 职位类别：医药技术研发人员
职位描述
Contribute in Developing and deploys technology standards and its applications through assets and products.
Provides technical expertise to External manufacturing in ensuring product end to end life cycle Management.
Technically support product life cycle management (investigation, troubleshooting etc.) partnering with VCM, CMC, PDMS and all JSC functions.
Provide expertise and resources to other TO platform, upon request, acts as a technical co- ordinator to external manufacturing group / SBS for technical scouting and due diligence for the current product portfolio / in-licensing.
Owns and executes Initiatives and projects related to network reconfiguration, major cost improvement programs, process improvements, implementation of new capabilities and capacity.
Contributes to business planning strategies in partnership with PES Manufacturing and PES Regional Lead and translates business goals into project objectives.
Develop relationships with Key Stakeholders, like PES Regional Lead, PES Site Lead, ESI-Q, PDMS, TO Platforms, Quality, VCM, CM, PM …...
Provide and organize technical expertise to External Manufacturing in ensuring consistent production of J&J marketed pharmaceutical products manufactured by External manufacturer / Third Party Manufacturers.
Act as a technical co-coordinator and consultant to the PES, PM and CM organizations to support technically in the scouting and due-diligence for the current product portfolio existing in external manufacturing.
Provide technical expertise to the CM and PES organizations for localization / Glocalization and supporting in due diligence of facility and products/ process fit technical assessment.
Assess and support, in agreement with PDMS organization (R&D), the execution for technical manufacturing process /formula modifications and introduction of New Product and Second Generation Development (in alignment with TLI or assuming the role of TLI/DPTO).
Assess and support PDMS in innovation of new technology scouting, novel manufacturing etc.
- Support technical assessment,
- Building business case,
- Support the implementation.
Lead the Technology Transfer activity of drug products as per regional Guidelines & J&J Quality Standards according to approved budget and timeline.
Prepare and ensure technical project scope and align with all stakeholders during project definition and execution.
Prepare and drive timely decisions within the project team and with relevant commercial and operational management .
Prepare, support and execute local and regional technology transfer projects in terms of project risks, budget, quality/scope and timings according to state-of-the art project management methodology.
Execute the Process Validations/PPQ as part of Technology Transfer in cGMP environment.
Execute introduction and transfer of products to External manufacturer / Third Party manufacturers for worldwide supplies / regional supplies.
Execute Technical Assessment & subsequent implementation for minor technical manufacturing process modifications as requested by the Manufacturer or Commercial groups.
Strives for developmental opportunities and initiates / proactively seeks for corrective actions as necessary.
University Degree (M.Pharm / M.Tech in Pharmaceutical Sciences, or Pharmaceutical Engineering, Chemistry or Engineering).
Fluent in English and with fluency in another major regional language desirable.
8-10 years of experience in Pharmaceutical Development, Scale up, Technology Transfer and /or manufacturing on oral dosage form and topical presentations in the region, in at least two different functions.
At least two years’ experience in External manufacturing /Third Party Technology Transfers and project management is desirable.
Profound Technology understanding of
The following final dosage presentations (minimum of two): Oral Dosage forms (Solids and Liquids), Semi-solids, or Parenterals & Transdermal drug delivery systems.
Pharmaceutical development of the following Oral Dosage forms (minimum of two): Solid Orals, Liquid Orals, Semi solids, Parenterals & Transdermal drug delivery systems (Minimum of two).
Global, and Regional regulatory requirements.
Fair knowledge on Product development/scale up/technology transfer regulations pertaining to ICH/USFDA/EMEA/Asia Pacific.
Knowledge on regional pharmaceutical manufacturing environment for Asia Pacific.
Good Manufacturing Practices, quality and compliance.
Process Validations / PPQ / CPV.
Cleaning validation.
Can prepare strategy and business case for technology transfer projects together with external manufacturing team and operating Companies.
Understands the needs of the Manufacturing Excellence Locally and Regionally and its platform.
Applies state-of-the-art project management methodology to manage project risks, budget, quality/scope and timings.
Can drive execution of project activities in the project team without formal reporting lines.
Can communicate and network across functions, regions and cultures, especially Asia Pacific and Europe / US.
公司介绍
本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。
目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。
2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。
联系方式
- Email：tmao3@its.jnj.com
- 公司地址：北京市朝阳区建国路77号华贸写字楼3座 (邮编：100025)