Research Scientist I, Stability Operations
苏州百特医疗用品有限公司
- 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:2013-10-15
- 工作地点:苏州
- 招聘人数:若干
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:医药技术研发人员
职位描述
Job Description:
1. Design technically sound stability studies for liquid parenteral pharmaceutical products that meet ChP, EP, sFDA, and ICH criteria for establishment of product expiry. Write protocols, conduct studies, and write reports.
2. Independently generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
3. Understand and apply statistical methods as needed to justify/establish appropriate product expiry.
4. Understand application of accelerated stability studies to establishment of expiry including projection of stability under different storage temperatures/conditions.
5. Understand and apply interpretation of analytical methods and determination of stability indicating analytical methods, including HPLC chromatographic separation, UV/visible absorption, particulate matter, pH, to ensure appropriate testing is conducted to fully characterize stability profile of products. Participates in lab investigations as author of technical evaluations that characterize the stability trending of suspect data.
6. Sought out by other teams and individuals to offer technical advice; Serve as technical consultant to research and manufacturing personnel in providing stability assessments and requirements for product enhancements/changes.
7. Develop products/processes (design, quality improvements, research techniques, etc.) incorporating multiple tasks within area of expertise.
8. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them as needed to increase product/processes acceptance, quality and reliability.
9. Develop new or improved techniques and procedures around specific tasks; write and implement SOP's. Develop research outlines for large scientific projects. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
10. Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
11. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
12. Present research results at external conferences, publish articles in journals and/or file patents.
13. Must be able to supervise and/or direct the laboratory work for lower level research associates.
Requirements:
1. Must possess strong knowledge of scientific disciplines, including statistical analysis, analytical chemistry, organic chemistry, and solid knowledge of related disciplines, plus knowledge of quality and general business systems.
2. Must possess strong ability to negotiate for resources and influence others internally and externally.
3. Must be able to challenge the status quo.
4. Can comfortably handle risk and uncertainty; can decide and act without having the total picture.
5. Fluent in Chinese and English language with reasonable speaking and writing skills.
6. MS with at least 6-8 years, or PhD with at least 2-4 years of relevant experience. GMP/GLP research experience is essential.
7. Lab experience including leadership of technical teams, and project management experience is desirable.
8. Experience designing registration stability studies and evaluating stability data is essential.
1. Design technically sound stability studies for liquid parenteral pharmaceutical products that meet ChP, EP, sFDA, and ICH criteria for establishment of product expiry. Write protocols, conduct studies, and write reports.
2. Independently generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
3. Understand and apply statistical methods as needed to justify/establish appropriate product expiry.
4. Understand application of accelerated stability studies to establishment of expiry including projection of stability under different storage temperatures/conditions.
5. Understand and apply interpretation of analytical methods and determination of stability indicating analytical methods, including HPLC chromatographic separation, UV/visible absorption, particulate matter, pH, to ensure appropriate testing is conducted to fully characterize stability profile of products. Participates in lab investigations as author of technical evaluations that characterize the stability trending of suspect data.
6. Sought out by other teams and individuals to offer technical advice; Serve as technical consultant to research and manufacturing personnel in providing stability assessments and requirements for product enhancements/changes.
7. Develop products/processes (design, quality improvements, research techniques, etc.) incorporating multiple tasks within area of expertise.
8. Incorporate knowledge of customer use and product design to predict product effectiveness/anticipate potential failures. Analyze executed designs and results and modify them as needed to increase product/processes acceptance, quality and reliability.
9. Develop new or improved techniques and procedures around specific tasks; write and implement SOP's. Develop research outlines for large scientific projects. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
10. Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
11. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
12. Present research results at external conferences, publish articles in journals and/or file patents.
13. Must be able to supervise and/or direct the laboratory work for lower level research associates.
Requirements:
1. Must possess strong knowledge of scientific disciplines, including statistical analysis, analytical chemistry, organic chemistry, and solid knowledge of related disciplines, plus knowledge of quality and general business systems.
2. Must possess strong ability to negotiate for resources and influence others internally and externally.
3. Must be able to challenge the status quo.
4. Can comfortably handle risk and uncertainty; can decide and act without having the total picture.
5. Fluent in Chinese and English language with reasonable speaking and writing skills.
6. MS with at least 6-8 years, or PhD with at least 2-4 years of relevant experience. GMP/GLP research experience is essential.
7. Lab experience including leadership of technical teams, and project management experience is desirable.
8. Experience designing registration stability studies and evaluating stability data is essential.
公司介绍
特别注明:苏州百特的所有招聘岗位仅通过圆才网和前程无忧网进行发布和收集简历!苏州百特的联系地址只有一个,白榆路27号。
每一天,百特影响着数以百万计的生命,我们凭借必要的医院和肾科产品与服务应对重大健康需求。在全球,几乎每个医院的每个科室,乃至每一楼层,都能发现百特产品与疗法的身影。同时,百特也出现在诊所和患者家中。
Every day, Millions of lives relay on Baxter, Our products and service are essential building blocks of healthcare. Baxter products and treatment are found almost in everyplace, in every hospital at every Department even on every floor. Meanwhile, Baxter is there, not only the clinic but also our patient home.
百特于上世纪80年代来到中国,是***进入中国医疗市场的大型跨国医疗企业之一。秉承“拯救并延续生命”的企业使命,百特专注于协助提升医疗标准、扩大医疗可及性和回馈社会等关键性工作,为中国患者的生命和生活质量做出有意义的贡献,助力中国医疗事业的可持续发展。
In the 80s Baxter has come to China which is one of the earliest multinational medical enterprise, Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations, also delivering contribution to our patient and their Quality lives meanwhile it will be supportive of sustainable development for Chinese medical treatment cause
苏州百特医疗用品有限公司成立于1995年, 是百特在中国建立的***家独资工厂,主要生产静脉输液袋、腹膜透析袋及相关组件,以用于静脉输注及腹膜透析治疗。我们始终严格执行中国质量管理体系,确保我们的产品以***质量和安全标准为患者及医护人员服务。目前, 560多名员工正运用最创新和先进的制造技术,为中国大陆、中国台湾、新加坡、澳大利亚、菲律宾及泰国等国家和地区的客户提供优质高效的医疗产品,为依赖于百特产品的患者带去有意义的改变。
Suzhou Baxter healthcare co., LTD is founded in 1995, This is the first sole plant in China. Baxter Suzhou produced venous transfusion container, PD bag and other related components which used in PD and venoclysis treatment, In order to provide the high-quality product, and let our customers using safety. Baxter Suzhou not only follow up the quality policy of Baxter headquarters, but also carry out the quality management system of China strictly as well ,At present, more than 560 employees are using the latest manufacturing technology to provide high quality medical products for customers comes from China Taiwan, India, Australia and the Philippines.
我们的理念是注重结果、客户导向;我们的价值观是正直诚实、坦诚沟通、承责力行;我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业,期盼更多优秀人才的加入,我们承诺为您提供充满活力的工作和成长环境,与百特共筑未来!
每一天,百特影响着数以百万计的生命,我们凭借必要的医院和肾科产品与服务应对重大健康需求。在全球,几乎每个医院的每个科室,乃至每一楼层,都能发现百特产品与疗法的身影。同时,百特也出现在诊所和患者家中。
Every day, Millions of lives relay on Baxter, Our products and service are essential building blocks of healthcare. Baxter products and treatment are found almost in everyplace, in every hospital at every Department even on every floor. Meanwhile, Baxter is there, not only the clinic but also our patient home.
百特于上世纪80年代来到中国,是***进入中国医疗市场的大型跨国医疗企业之一。秉承“拯救并延续生命”的企业使命,百特专注于协助提升医疗标准、扩大医疗可及性和回馈社会等关键性工作,为中国患者的生命和生活质量做出有意义的贡献,助力中国医疗事业的可持续发展。
In the 80s Baxter has come to China which is one of the earliest multinational medical enterprise, Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations, also delivering contribution to our patient and their Quality lives meanwhile it will be supportive of sustainable development for Chinese medical treatment cause
苏州百特医疗用品有限公司成立于1995年, 是百特在中国建立的***家独资工厂,主要生产静脉输液袋、腹膜透析袋及相关组件,以用于静脉输注及腹膜透析治疗。我们始终严格执行中国质量管理体系,确保我们的产品以***质量和安全标准为患者及医护人员服务。目前, 560多名员工正运用最创新和先进的制造技术,为中国大陆、中国台湾、新加坡、澳大利亚、菲律宾及泰国等国家和地区的客户提供优质高效的医疗产品,为依赖于百特产品的患者带去有意义的改变。
Suzhou Baxter healthcare co., LTD is founded in 1995, This is the first sole plant in China. Baxter Suzhou produced venous transfusion container, PD bag and other related components which used in PD and venoclysis treatment, In order to provide the high-quality product, and let our customers using safety. Baxter Suzhou not only follow up the quality policy of Baxter headquarters, but also carry out the quality management system of China strictly as well ,At present, more than 560 employees are using the latest manufacturing technology to provide high quality medical products for customers comes from China Taiwan, India, Australia and the Philippines.
我们的理念是注重结果、客户导向;我们的价值观是正直诚实、坦诚沟通、承责力行;我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业,期盼更多优秀人才的加入,我们承诺为您提供充满活力的工作和成长环境,与百特共筑未来!
联系方式
- 公司地址:百特天津工厂