TSMS Specialist-Elanco External Manufacturing
礼来国际贸易（上海）有限公司
- 公司规模：1000-5000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：2017-03-08
- 工作地点：上海-静安区
- 招聘人数：1人
- 职位月薪：1-1.5万/月
- 职位类别：医药技术研发管理人员
职位描述
职位描述：
Position Brand Description:
Elanco is a global research-based company that develops and markets products to improve the health and production of animals in more than 100 countries, and is an exciting division of Eli Lilly and Company. Elanco products enhance animal health, wellness, welfare and performance to help the food industry produce an abundant supply of safe and affordable food.
The TSMS is responsible for the supervision of TSMS performance of EEM China to provide the technical support and innovational solutions to the all external manufacturing including contract manufacturing operations, suppliers and business partners in the People’s Republic of China by Contract Manufacturing Organizations.
Key Objectives/Deliverables:
External suppliers or business partners governance
? Have a good capability to govern on TSMS operations on suppliers or business partners.
? Support TSMS Leader to establish/ Maintain TSMS System of EEM China at key suppliers or partners.
? Improve the technical capabilities to meet with suppliers or partners from China.
? Complete the following duties in governance of key suppliers or partners:
o Routine support of Bio products and intermediates.
o Working with cross functional groups to troubleshoot issues arising at suppliers or partners.
o Review manufacturing process data for adverse trends and productivity opportunities.
? Work with individuals in process development and manufacturing components to implement new processes in manufacturing.
? Perform the incident/investigations (i.e., from stability, from APRs, from storage)
o Review/assess change controls prepared by the suppliers for the potential impact to SISPQ
o Work with cross functional groups for timely resolution and closure of site specific CAPA
? Guide the suppliers or business partners to complete process validation
CMO Governance:
? Have a good capability to govern on daily TSMS operations on CMOs.
? Perform/complete TSMS Tasks and develop technical agenda for CMO business.
? Participate to establish/ Maintain TSMS System of EEM China
? Support TSMS leader to develop the technical capabilities to meet with CMO business from China.
? Maintain and strengthen relevant network with EEM TSMS globally.
? Complete the other duties assigned by TSMS leader at EEM China:
o Responsible for CMO business to play high performance work in following areas:
o Development and maintenance of manufacturing instructions for Elanco governed products.
o Day to day support of products for Elanco governed products.
o Establish working relationship with the Elanco Manufacturing Science and Technology network
o Working with cross functional groups to troubleshoot issues arising at the contract manufacturing sites.
o Review manufacturing process data for adverse trends and productivity opportunities.
? Work with individuals in process development and manufacturing components to implement new processes in manufacturing.
? Review APRs from the contract manufacturer and write APR to fill identified gaps to the respective GQS.
? Perform the incident/deviation/investigations (i.e., from stability, from APRs, from storage)
o Review deviations prepared by the contract manufacturer for the potential impact to SISPQ
o Work with cross functional groups for timely resolution and closure of site specific deviations
? Conduct/Provide technical support for manufacturing process validation
o Review/write process validation protocols.
Minimum Requirements:
? Three to five years of experience in bio products (Large scale or Small scale) process technical area (Classical fermentation experienced are preferred) and with related working experience of HSE (Particular for experience of process safety and biosafety).
? Or experience specifically/ or Biotech (Classical fermentation /protein / parenteral process experience)
? Capable of speaking, writing, and reading English fluently
? Potentially good leadership and strong communication skill (Fluent in English and Chinese (Speak, Read & Write)
? Independent technical thinking and Good teamwork
? With following specified experience:
? Experience specifically/ or Biotech (Fermentation / Vaccine / parenteral process experience).
? Strong problem solving capabilities including strategic and creative thinking
? Strong interpersonal/communication skills: verbal and written
? Ability to handle multiple priorities and deal with ambiguity
? Understanding of global cGMPs for API manufacturing and drug products.
Additional Preferences:
? Understanding of analytical methods.
? Bio products R&D experience
? API and Drug Product Packaging Experience
Education Requirements:
Advanced Science degree (e.g. Chemistry, Engineering, Biochemistry, Industrial Microbiologist) or Bachelors of Science degree with equivalent work experience.
Other Information:
Approximately 30-35% travel: domestically (25%) and internationally (10%).
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Position Brand Description:
Elanco is a global research-based company that develops and markets products to improve the health and production of animals in more than 100 countries, and is an exciting division of Eli Lilly and Company. Elanco products enhance animal health, wellness, welfare and performance to help the food industry produce an abundant supply of safe and affordable food.
The TSMS is responsible for the supervision of TSMS performance of EEM China to provide the technical support and innovational solutions to the all external manufacturing including contract manufacturing operations, suppliers and business partners in the People’s Republic of China by Contract Manufacturing Organizations.
Key Objectives/Deliverables:
External suppliers or business partners governance
? Have a good capability to govern on TSMS operations on suppliers or business partners.
? Support TSMS Leader to establish/ Maintain TSMS System of EEM China at key suppliers or partners.
? Improve the technical capabilities to meet with suppliers or partners from China.
? Complete the following duties in governance of key suppliers or partners:
o Routine support of Bio products and intermediates.
o Working with cross functional groups to troubleshoot issues arising at suppliers or partners.
o Review manufacturing process data for adverse trends and productivity opportunities.
? Work with individuals in process development and manufacturing components to implement new processes in manufacturing.
? Perform the incident/investigations (i.e., from stability, from APRs, from storage)
o Review/assess change controls prepared by the suppliers for the potential impact to SISPQ
o Work with cross functional groups for timely resolution and closure of site specific CAPA
? Guide the suppliers or business partners to complete process validation
CMO Governance:
? Have a good capability to govern on daily TSMS operations on CMOs.
? Perform/complete TSMS Tasks and develop technical agenda for CMO business.
? Participate to establish/ Maintain TSMS System of EEM China
? Support TSMS leader to develop the technical capabilities to meet with CMO business from China.
? Maintain and strengthen relevant network with EEM TSMS globally.
? Complete the other duties assigned by TSMS leader at EEM China:
o Responsible for CMO business to play high performance work in following areas:
o Development and maintenance of manufacturing instructions for Elanco governed products.
o Day to day support of products for Elanco governed products.
o Establish working relationship with the Elanco Manufacturing Science and Technology network
o Working with cross functional groups to troubleshoot issues arising at the contract manufacturing sites.
o Review manufacturing process data for adverse trends and productivity opportunities.
? Work with individuals in process development and manufacturing components to implement new processes in manufacturing.
? Review APRs from the contract manufacturer and write APR to fill identified gaps to the respective GQS.
? Perform the incident/deviation/investigations (i.e., from stability, from APRs, from storage)
o Review deviations prepared by the contract manufacturer for the potential impact to SISPQ
o Work with cross functional groups for timely resolution and closure of site specific deviations
? Conduct/Provide technical support for manufacturing process validation
o Review/write process validation protocols.
Minimum Requirements:
? Three to five years of experience in bio products (Large scale or Small scale) process technical area (Classical fermentation experienced are preferred) and with related working experience of HSE (Particular for experience of process safety and biosafety).
? Or experience specifically/ or Biotech (Classical fermentation /protein / parenteral process experience)
? Capable of speaking, writing, and reading English fluently
? Potentially good leadership and strong communication skill (Fluent in English and Chinese (Speak, Read & Write)
? Independent technical thinking and Good teamwork
? With following specified experience:
? Experience specifically/ or Biotech (Fermentation / Vaccine / parenteral process experience).
? Strong problem solving capabilities including strategic and creative thinking
? Strong interpersonal/communication skills: verbal and written
? Ability to handle multiple priorities and deal with ambiguity
? Understanding of global cGMPs for API manufacturing and drug products.
Additional Preferences:
? Understanding of analytical methods.
? Bio products R&D experience
? API and Drug Product Packaging Experience
Education Requirements:
Advanced Science degree (e.g. Chemistry, Engineering, Biochemistry, Industrial Microbiologist) or Bachelors of Science degree with equivalent work experience.
Other Information:
Approximately 30-35% travel: domestically (25%) and internationally (10%).
职能类别： 医药技术研发管理人员
公司介绍
美国礼来制药（eli lilly and company）是一家全球性的以研发为基础的医药公司，创立于1876年，总部位于美国印地安那州印第安纳波利斯市，业务遍及全球 125 个国家和地区。礼来致力于为全人类提供以药物为基础的创新医疗保健方案，使人们生活得更长久、更健康、更有活力。
礼来制药与中国的渊源可以追溯到二十世纪初页。礼来于1918年来到中国，并将其第一个海外代表处设在上海，从而迈出了全球化的第一步。几经风雨历练，礼来于1993年重返中国。二十年多来，礼来本着“植根中国，造福中国”的理念，着力拓展在华业务，目前已经形成从研发、生产到商业运营的全产业链格局。礼来中国如今已成长为礼来全球第二大分支机构。
礼来在苏州建立有礼来苏州制药有限公司，在上海张江高科技园区建有礼来中国研发中心，并在全国数十个城市建立了办事机构，在中国拥有员工四千余人，目前公司业务已经深入到中国近四百个城市，礼来连续十余年在中国保持两位数的增速。
礼来在中国的许多医药领域居领先地位，如抗生素、中枢神经、肿瘤、内分泌等。礼来的品牌希刻劳、稳可信、百优解、再普乐、欣百达、健择、力比泰、易维特、复泰奥、希爱力、人工胰岛素优泌林及其***伴侣优伴，人胰岛素类似物优泌乐、欧唐宁等已被公认为创新的药物。它们挽救了病人生命、提高了大众的生活品质，同时为患者、医务工作者和医疗保障体系提供了更有价值的治疗选择, 降低了治疗成本。
礼来在中国的经营原则与我们在全球的原则完全一致，充分体现了“诚信至上,追求卓越,以人为本”的信条。礼来的宗旨是成为一名诚信的中国企业公民，通过“植根中国，造福中国”，尽全力为中国人民提供最新和最高质量的药品，挽救病人的生命，提高大众的生活品质。
礼来致力于成为中国医疗保健领域的主要战略伙伴，高瞻远瞩，长期回报社会。重返中国二十多年来，礼来为发展公共卫生事业、社会救助活动投入了巨大的热忱。同时，礼来通过开展形式各异的大众教育活动，传递疾病信息，普及健康知识，提高大众的生活品质。由于我们在公益事业方面的突出表现，礼来相继荣获了“光明公益奖”、“世界500强企业慈善公益榜”、中国制药企业社会责任“孺子牛奖”、“中国企业社会责任特别大奖”、及卫生部授予的“特别贡献奖”等多个奖项。
礼来中国的员工价值主张是“享你未来”！具体到整体回报的四个方面，礼来中国分别倡导业享所得、家享关怀、才享卓越、心享悦然。
薪酬方面我们倡导业享所得。每一份努力，都让梦想离得更近。承担的职责越多，绩效越优秀，获得的薪酬回报也越高。
福利方面我们倡导家享关怀。每一程出发，都有关爱悉心相伴。我们希望关怀员工每个人生阶段不同的需求并提供支持，让每位员工都能享受美满无忧的人生。
个人发展方面我们倡导才享卓越。每一步成长，都有平台助力腾飞。我们致力于为每位员工提供全面的职业发展支持，助你成为令人艳羡的业界精英。
工作环境方面我们倡导心享悦然。每一次成功，都因身心自在其中。礼来不只是一家公司，它更像一个大家庭。我们希望每天都和志同道合的像家人一样的同事们一起奋斗，一起去取得成功，并一起分享成功的喜悦。
如果你一直想加入这家有着良好声誉的公司， 现在， 机会之门正在敞开！我们寻求优秀的你， 自信的你加入我们， 和礼来一起共同成长。无论你是经验丰富的专业人士， 还是胸怀壮志的应届毕业生，相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧，加入我们， 礼来将助你成就梦想！
详细信息请查阅礼来中国招聘官方网站http://www.lillychina.com/careers
礼来制药与中国的渊源可以追溯到二十世纪初页。礼来于1918年来到中国，并将其第一个海外代表处设在上海，从而迈出了全球化的第一步。几经风雨历练，礼来于1993年重返中国。二十年多来，礼来本着“植根中国，造福中国”的理念，着力拓展在华业务，目前已经形成从研发、生产到商业运营的全产业链格局。礼来中国如今已成长为礼来全球第二大分支机构。
礼来在苏州建立有礼来苏州制药有限公司，在上海张江高科技园区建有礼来中国研发中心，并在全国数十个城市建立了办事机构，在中国拥有员工四千余人，目前公司业务已经深入到中国近四百个城市，礼来连续十余年在中国保持两位数的增速。
礼来在中国的许多医药领域居领先地位，如抗生素、中枢神经、肿瘤、内分泌等。礼来的品牌希刻劳、稳可信、百优解、再普乐、欣百达、健择、力比泰、易维特、复泰奥、希爱力、人工胰岛素优泌林及其***伴侣优伴，人胰岛素类似物优泌乐、欧唐宁等已被公认为创新的药物。它们挽救了病人生命、提高了大众的生活品质，同时为患者、医务工作者和医疗保障体系提供了更有价值的治疗选择, 降低了治疗成本。
礼来在中国的经营原则与我们在全球的原则完全一致，充分体现了“诚信至上,追求卓越,以人为本”的信条。礼来的宗旨是成为一名诚信的中国企业公民，通过“植根中国，造福中国”，尽全力为中国人民提供最新和最高质量的药品，挽救病人的生命，提高大众的生活品质。
礼来致力于成为中国医疗保健领域的主要战略伙伴，高瞻远瞩，长期回报社会。重返中国二十多年来，礼来为发展公共卫生事业、社会救助活动投入了巨大的热忱。同时，礼来通过开展形式各异的大众教育活动，传递疾病信息，普及健康知识，提高大众的生活品质。由于我们在公益事业方面的突出表现，礼来相继荣获了“光明公益奖”、“世界500强企业慈善公益榜”、中国制药企业社会责任“孺子牛奖”、“中国企业社会责任特别大奖”、及卫生部授予的“特别贡献奖”等多个奖项。
礼来中国的员工价值主张是“享你未来”！具体到整体回报的四个方面，礼来中国分别倡导业享所得、家享关怀、才享卓越、心享悦然。
薪酬方面我们倡导业享所得。每一份努力，都让梦想离得更近。承担的职责越多，绩效越优秀，获得的薪酬回报也越高。
福利方面我们倡导家享关怀。每一程出发，都有关爱悉心相伴。我们希望关怀员工每个人生阶段不同的需求并提供支持，让每位员工都能享受美满无忧的人生。
个人发展方面我们倡导才享卓越。每一步成长，都有平台助力腾飞。我们致力于为每位员工提供全面的职业发展支持，助你成为令人艳羡的业界精英。
工作环境方面我们倡导心享悦然。每一次成功，都因身心自在其中。礼来不只是一家公司，它更像一个大家庭。我们希望每天都和志同道合的像家人一样的同事们一起奋斗，一起去取得成功，并一起分享成功的喜悦。
如果你一直想加入这家有着良好声誉的公司， 现在， 机会之门正在敞开！我们寻求优秀的你， 自信的你加入我们， 和礼来一起共同成长。无论你是经验丰富的专业人士， 还是胸怀壮志的应届毕业生，相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧，加入我们， 礼来将助你成就梦想！
详细信息请查阅礼来中国招聘官方网站http://www.lillychina.com/careers
联系方式
- 公司地址：上班地址：北京