Technical Steward/固体制剂技术专家
Pharma-北京诺华制药有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-04-30
- 工作地点:北京-昌平区
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:面议
- 职位类别:药品生产/质量管理 医药技术研发人员
职位描述
Knowledge management:
? Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
? Provides and assures the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators.
? Assures that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
Subject Matter Expert SME for Technology platform:
? Deep Subject Matter Expertise for specific Technology Platform (e.g. film coating etc) or pharmaceutical processes (e.g. galenical, chemical, biologics – upstream or downstream, etc.) following process product/process transfer or handover from launch to commercial production.
? Designs and controls optimization projects relevant to his/her specific expertise.
? Provides SME expertise to perform process characterizion of the related pharmaceutical processes to increase robustness and sustainability.
? Supports Process Experts and Product Stewards in trouble shooting by providing second level of specialist expertise as Subject Matter Experts and by harmonising and optimising related technical processes across the units.
Single Point Of Contact (SPoC) for the technology
? Acts as the SPoC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment (e.g., manufacturing equipment, Process Analytical Technologies PAT).
? Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
Selection of process equipment
? Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements (URS).
Audit support
? Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
? Participate in due diligence team, where applicable, for in-license projects.
Training
? Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
? Provide the necessary training and education on related technologies to Process Experts, Product Stewards and Operators.
? Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
? Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
? Provides and assures the fundamental knowledge in the specific area of expertise through the provision of regular training and education programs for Process Experts and Operators.
? Assures that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
Subject Matter Expert SME for Technology platform:
? Deep Subject Matter Expertise for specific Technology Platform (e.g. film coating etc) or pharmaceutical processes (e.g. galenical, chemical, biologics – upstream or downstream, etc.) following process product/process transfer or handover from launch to commercial production.
? Designs and controls optimization projects relevant to his/her specific expertise.
? Provides SME expertise to perform process characterizion of the related pharmaceutical processes to increase robustness and sustainability.
? Supports Process Experts and Product Stewards in trouble shooting by providing second level of specialist expertise as Subject Matter Experts and by harmonising and optimising related technical processes across the units.
Single Point Of Contact (SPoC) for the technology
? Acts as the SPoC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment (e.g., manufacturing equipment, Process Analytical Technologies PAT).
? Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
Responsible to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
Selection of process equipment
? Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements (URS).
Audit support
? Maintain their work in inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review regulatory documentation.
? Participate in due diligence team, where applicable, for in-license projects.
Training
? Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
? Provide the necessary training and education on related technologies to Process Experts, Product Stewards and Operators.
? Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
公司介绍
北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药,涵盖的疾病领域包括:心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。
“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年,总部设在北京,隶属于瑞士诺华公司。
诺华公司致力于为患者及社会提供创新医药保健解决方案,以满足其日益变化的健康需求。2011年,集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元(去除减值及摊销后为92亿美元)。诺华集团总部位于瑞士巴塞尔,业务遍及全球140多个国家和地区,拥有124,000位全职员工。诺华集团立足在中国的长期发展,重要战略投资包括位于上海的综合性生物医学研发中心,以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息,敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。
“诺华”中文取意“承诺中华”,即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年,总部设在北京,隶属于瑞士诺华公司。
诺华公司致力于为患者及社会提供创新医药保健解决方案,以满足其日益变化的健康需求。2011年,集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元(去除减值及摊销后为92亿美元)。诺华集团总部位于瑞士巴塞尔,业务遍及全球140多个国家和地区,拥有124,000位全职员工。诺华集团立足在中国的长期发展,重要战略投资包括位于上海的综合性生物医学研发中心,以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息,敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。
联系方式
- Email:staffing.center@novartis.com
- 公司地址:上班地址:建国门外大街1号国贸大厦2座